Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease (PHOTON)

July 18, 2025 updated by: Regeneron Pharmaceuticals

A Randomized, Double-Masked, Active-Controlled Phase 2/3 Study of the Efficacy and Safety of High-Dose Aflibercept in Patients With Diabetic Macular Edema

The primary objective of the study is to determine if treatment with high-dose aflibercept (HD) at intervals of 12 or 16 weeks provides non-inferior best corrected visual acuity (BCVA) compared to aflibercept dosed every 8 weeks.

The secondary objectives of the study are as follows:

  • To determine the effect of HD vs. aflibercept on anatomic and other visual measures of response
  • To evaluate the safety, immunogenicity, and pharmacokinetics (PK) of aflibercept

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
660

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2H 0C8
        • Regeneron Study Site
    • Ontario
      • Mississauga, Ontario, Canada, L4W 1W9
        • Regeneron Study Site
      • North York, Ontario, Canada, M3C 0G9
        • Regeneron Study Site
    • Quebec
      • Sherbrooke, Quebec, Canada, J1G 2V4
        • Regeneron Study Site
  • Czechia
      • Pardubice, Czechia, 530 02
        • Regeneron Study Site
      • Prague 5, Czechia, 150 00
        • Regeneron Study Site
      • Praha 10, Czechia, 100 34
        • Regeneron Study Site
      • Praha 2, Czechia, 128 08
        • Regeneron Study Site
  • Germany
    • Mecklenburg-Westfalen
      • Neubrandenburg, Mecklenburg-Westfalen, Germany, 17036
        • Regeneron Study Site
    • Nordrhein-Westfalen
      • Gottingen, Nordrhein-Westfalen, Germany, 37075
        • Regeneron Study Site
      • Munster, Nordrhein-Westfalen, Germany, 48145
        • Regeneron Study Site
  • Hungary
      • Budapest, Hungary, H-1085
        • Regeneron Study Site
      • Budapest, Hungary, H-1106
        • Regeneron Study Site
      • Budapest, Hungary, H-1133
        • Regeneron Study Site
      • Budapest, Hungary, H-1145
        • Regeneron Study Site
      • Debrecen, Hungary, H-4032
        • Regeneron Study Site
      • Szeged, Hungary, H-6720
        • Regeneron Study Site
    • Baranya
      • Pecs, Baranya, Hungary, H-7621
        • Regeneron Study Site 1
    • Vas
      • Szombathely, Vas, Hungary, H-9700
        • Regeneron Study Site
    • Zala Megye
      • Zalaegerszeg, Zala Megye, Hungary, H-8900
        • Regeneron Study Site
  • Japan
      • Fukuoka, Japan, 812-0011
        • Regeneron Study Site
      • Fukuoka, Japan, 819-8585
        • Regeneron Study Site
      • Kagoshima, Japan, 890-8520
        • Regeneron Study Site
      • Osaka, Japan, 545-8586
        • Regeneron Study Site
      • Saitama, Japan, 330-8553
        • Regeneron Study Site
      • Tokushima, Japan, 770-8503
        • Regeneron Study Site
    • Aichi
      • Nagakute, Aichi, Japan, 480-1195
        • Regeneron Study Site
      • Nagoya, Aichi, Japan, 466-8560
        • Regeneron Study Site
      • Nagoya, Aichi, Japan, 467-8602
        • Regeneron Study Site
    • Fukui
      • Yoshida-Gun, Fukui, Japan, 910-1193
        • Regeneron Study Site
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830-0011
        • Regeneron Study Site
    • Fukushima
      • Koriyama, Fukushima, Japan, 963-8052
        • Regeneron Study Site
    • Hokkaido
      • Hakodate, Hokkaido, Japan, 041-0851
        • Regeneron Study Site
    • Hyogo
      • Kobe, Hyogo, Japan, 650-0017
        • Regeneron Study Site
    • Ibaraki
      • Mito, Ibaraki, Japan, 310-0845
        • Regeneron Study Site
      • Toride, Ibaraki, Japan, 302-0014
        • Regeneron Study Site
      • Tsuchiura-shi, Ibaraki, Japan, 300-0817
        • Regeneron Study Site
    • Kagawa
      • Kita-gun, Kagawa, Japan, 761-0793
        • Regeneron Study Site
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 216-8511
        • Regeneron Study Site
    • Nagano
      • Matsumoto, Nagano, Japan, 390-8621
        • Regeneron Study Site
    • Nagasaki
      • Nagasaki City, Nagasaki, Japan, 852-8501
        • Regeneron Study Site
    • Nara
      • Kashihara, Nara, Japan, 634-8522
        • Regeneron Study Site
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Regeneron Study Site
    • Saitama
      • Tokorozawa, Saitama, Japan, 359-8513
        • Regeneron Study Site
    • Shizuoka
      • Susono, Shizuoka, Japan, 410-1102
        • Regeneron Study Site
    • Tokyo
      • Chiyoda-ku, Tokyo, Japan, 101-8309
        • Regeneron Study Site
      • Hachioji, Tokyo, Japan, 193-0998
        • Regeneron Study Site
      • Itabashi-ku, Tokyo, Japan, 173-0015
        • Regeneron Study Site
      • Meguro-ku, Tokyo, Japan, 152-8902
        • Regeneron Study Site
    • Totigi
      • Shimotsuke-shi, Totigi, Japan, 329-0498
        • Regeneron Study Site
    • Yamaguchi
      • Ube, Yamaguchi, Japan, 755-8505
        • Regeneron Study Site
  • Puerto Rico
      • Arecibo, Puerto Rico, 00612
        • Regeneron Study Site
  • United Kingdom
      • London, United Kingdom, EC1V 2PD
        • Regeneron Study Site
    • Tyne And Wear
      • Sunderland, Tyne And Wear, United Kingdom, SR2 9HP
        • Regeneron Study Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85021
        • Regeneron Study Site
    • California
      • Arcadia, California, United States, 91006
        • Regeneron Study Site
      • Beverly Hills, California, United States, 90211
        • Regeneron Study Site
      • Campbell, California, United States, 95008
        • Regeneron Study Site
      • Encino, California, United States, 91436
        • Regeneron Study Site
      • Fullerton, California, United States, 92835
        • Regeneron Study Site
      • Huntington Beach, California, United States, 92647
        • Regeneron Study Site
      • Long Beach, California, United States, 90807
        • Regeneron Study Site
      • Palo Alto, California, United States, 94303
        • Regeneron Study Site
      • Pasadena, California, United States, 91107
        • Regeneron Study Site
      • Poway, California, United States, 92064
        • Regeneron Study Site
      • Rancho Cordova, California, United States, 95670
        • Regeneron Study Site
      • Riverside, California, United States, 92505
        • Regeneron Study Site
      • Torrance, California, United States, 90509
        • Regeneron Study Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Regeneron Study Site
      • Durango, Colorado, United States, 81301
        • Regeneron Study Site
      • Lakewood, Colorado, United States, 80228
        • Regeneron Study Site
    • Connecticut
      • Waterford, Connecticut, United States, 06385
        • Regeneron Study Site
    • Florida
      • Clearwater, Florida, United States, 33761
        • Regeneron Study Site
      • Fort Lauderdale, Florida, United States, 33308
        • Regeneron Study Site
      • Fort Myers, Florida, United States, 33912
        • Regeneron Study Site
      • Jacksonville, Florida, United States, 32216
        • Regeneron Study Site
      • Lakeland, Florida, United States, 33805
        • Regeneron Study Site
      • Largo, Florida, United States, 33770
        • Regeneron Study Site
      • Melbourne, Florida, United States, 32901
        • Regeneron Study Site
      • Miami, Florida, United States, 33126
        • Regeneron Study Site
      • Orlando, Florida, United States, 32806
        • Regeneron Study Site
      • Pinellas Park, Florida, United States, 33782
        • Regeneron Study Site
      • Plantation, Florida, United States, 33324
        • Regeneron Study Site
      • Saint Petersburg, Florida, United States, 33711
        • Regeneron Study Site
      • Stuart, Florida, United States, 34994
        • Regeneron Study Site
      • Winter Haven, Florida, United States, 33880
        • Regeneron Study Site
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Regeneron Study Site
      • Marietta, Georgia, United States, 30060
        • Regeneron Study Site 1
      • Marietta, Georgia, United States, 30060
        • Regeneron Study Site 2
    • Hawaii
      • 'Aiea, Hawaii, United States, 96701
        • Regeneron Study Site
    • Illinois
      • Oak Forest, Illinois, United States, 60452
        • Regeneron Study Site
      • Springfield, Illinois, United States, 62703
        • Regeneron Study Site
      • Springfield, Illinois, United States, 62704
        • Regeneron Study Site
    • Indiana
      • Carmel, Indiana, United States, 46290
        • Regeneron Study Site
    • Kansas
      • Shawnee Mission, Kansas, United States, 66204
        • Regeneron Study Site
    • Maryland
      • Baltimore, Maryland, United States, 21209
        • Regeneron Study Site
      • Hagerstown, Maryland, United States, 21740
        • Regeneron Study Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Regeneron Study Site
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Regeneron Study Site
    • Mississippi
      • Southaven, Mississippi, United States, 38671
        • Regeneron Study Site
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Regeneron Study Site
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Regeneron Study Site
      • Edison, New Jersey, United States, 08820
        • Regeneron Study Site
      • Teaneck, New Jersey, United States, 07666
        • Regeneron Study Site
    • New York
      • Great Neck, New York, United States, 11021
        • Regeneron Study Site
      • Liverpool, New York, United States, 13088
        • Regeneron Study Site
      • New York, New York, United States, 11221
        • Regeneron Study Site
      • Oceanside, New York, United States, 11572
        • Regeneron Study Site
      • Shirley, New York, United States, 02114
        • Regeneron Study Site
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Regeneron Study Site
      • Charlotte, North Carolina, United States, 28210
        • Regeneron Study Site
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Regeneron Study Site
      • Cincinnati, Ohio, United States, 45202
        • Regeneron Study Site
      • Cincinnati, Ohio, United States, 45242
        • Regeneron Study Site
      • Cleveland, Ohio, United States, 44130
        • Regeneron Study Site
      • Dublin, Ohio, United States, 43016
        • Regeneron Study Site
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Regeneron Study Site
      • Tulsa, Oklahoma, United States, 74114
        • Regeneron Study Site
    • Oregon
      • Portland, Oregon, United States, 97225
        • Regeneron Study Site
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
        • Regeneron Study Site
      • Kingston, Pennsylvania, United States, 18704
        • Regeneron Study Site
      • Monroeville, Pennsylvania, United States, 15146
        • Regeneron Study Site
    • South Carolina
      • Beaufort, South Carolina, United States, 29902
        • Regeneron Study Site
      • Ladson, South Carolina, United States, 29456
        • Regeneron Study Site
      • West Columbia, South Carolina, United States, 29169
        • Regeneron Study Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Regeneron Study Site
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Regeneron Study Site
      • Knoxville, Tennessee, United States, 37922
        • Regeneron Study Site
      • Nashville, Tennessee, United States, 37203
        • Regeneron Study Site
    • Texas
      • Abilene, Texas, United States, 79606
        • Regeneron Study Site
      • Bellaire, Texas, United States, 77401
        • Regeneron Study Site
      • San Antonio, Texas, United States, 78240
        • Regeneron Study Site 2
      • The Woodlands, Texas, United States, 77384
        • Regeneron Study Site
      • Willow Park, Texas, United States, 76087
        • Regeneron Study Site
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Regeneron Study Site 1
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Regeneron Study Site
      • Norfolk, Virginia, United States, 23502
        • Regeneron Study Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Regeneron Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Diabetic macular edema (DME) with central involvement in the study eye
  • Best corrected visual acuity (BCVA) early treatment diabetic retinopathy study (ETDRS) letter score of 78 to 24 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye with decreased vision determined to be primarily the result of DME
  • Willing and able to comply with clinic visits and study-related procedures
  • Provide informed consent signed by study participant or legally acceptable representative

Extension Phase: All randomized patients that complete visit 26, week 96, as long as the patient 1) provides informed consent and 2) no treatment for DME has been given in the study eye other than the randomized study treatment.

Key Exclusion Criteria:

  • Evidence of macular edema due to any cause other than diabetes mellitus in either eye
  • Active proliferative diabetic retinopathy in the study eye
  • IVT anti-VEGF treatment (aflibercept, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium) or panretinal laser photocoagulation (PRP) /macular laser photocoagulation within 12 weeks (84 days) or intraocular or periocular corticosteroids within 16 weeks (112 days) of the screening visit in the study eye
  • Prior IVT investigational agents in either eye (eg, anti-ang-2/anti-VEGF bispecific monoclonal antibodies, gene therapy, etc.) at any time
  • Treatment with ocriplasmin (JETREA®) in the study eye at any time

NOTE: Other Protocol Defined Inclusion/Exclusion Criteria Apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: aflibercept Q8
Administered every 8 weeks after a loading phase
Drug: aflibercept
Intravitreally (IVT) administered as a liquid formulation in a vial
Other Names:
  • BAY86-5321
  • EYLEA®
Experimental: High-Dose aflibercept Q12
Administered every 12 weeks after a loading phase
Drug: High-dose aflibercept
Intravitreally (IVT) administered as a liquid formulation in a vial
Experimental: High-Dose aflibercept Q16
Administered every 16 weeks after a loading phase
Drug: High-dose aflibercept
Intravitreally (IVT) administered as a liquid formulation in a vial

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Best Corrected Visual Acuity (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] Letter Score) in the Study Eye at Week 48
Time Frame: Baseline, Week 48
Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best).
Baseline, Week 48

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With a ≥2 Step Improvement From Baseline in Diabetic Retinopathy Severity Scale (DRSS) Score at Week 48
Time Frame: Baseline, Week 48
The DRSS was assessed according to the following scale: 10 = Diabetic retinopathy (DR) absent, 14 = DR questionable, 15 = DR questionable, 20 = Micro-aneurysms only, 35 = Mild Non-proliferative diabetic retinopathy (NPDR), 43 = Moderate NPDR, 47 = Moderately severe NPDR, 53 = Severe NPDR, 61 = Mild Proliferative diabetic retinopathy (PDR), 65 = Moderate PDR, 71 = High-risk PDR, 75 = High-risk PDR, 81 = Advanced PDR: fundus partially obscured, center of macula attached, 85 = Advanced PDR: posterior fundus obscured, or center of macula detached, 90 = cannot grade, even sufficiently for level 81 or 85.
Baseline, Week 48
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline at Week 48
Time Frame: Baseline, Week 48
Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best). Only one study eye per participant was analyzed within the study
Baseline, Week 48
Percentage of Participants With BCVA ≥69 Letters at Week 48
Time Frame: At Week 48
Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best).
At Week 48
Percentage of Participants Without Fluid at Foveal Center at Week 48
Time Frame: At Week 48
Retinal fluid status was evaluated using spectral domain optical coherence tomography (SD-OCT) on the study eye.
At Week 48
Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 48
Time Frame: Baseline, Week 48
Central Retinal Thickness (CRT) was measured in the study eye by spectral domain optical coherence tomography (SD-OCT).
Baseline, Week 48
Percentage of Participants Without Leakage on Fluorescein Angiography (FA) at Week 48
Time Frame: At Week 48
Leakage is the release of fluorescein dye from diseased retinal vessels.
At Week 48
Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Total Score at Week 48
Time Frame: Baseline, Week 48
Vision-specific quality of life is assessed with the NEI VFQ-25 (National Eye Institute Visual Function Questionnaire), i.e. a 25-item questionnaire that gives a score on a scale from 0 (worst) to 100 (best = no vision problems).
Baseline, Week 48
Systemic Pharmacokinetics (PK) of Aflibercept as Assessed by Plasma Concentrations Through Week 48
Time Frame: Through Week 48
Concentrations of Free Aflibercept in Plasma by Time and Treatment Group
Through Week 48
Change From Baseline in BCVA in the Study Eye in Participants With Both Baseline and Week 48 BCVA
Time Frame: Baseline, Week 48
Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best). (Per Statistical Analysis Plan (SAP) Version 2.0 Appendix 10.9 for US Only)
Baseline, Week 48
Change From 8-weeks Post Initial Treatment Phase in BCVA in the Study Eye in Participants With Both 8-weeks Post Initial Treatment Phase BCVA and Week 48 BCVA
Time Frame: Baseline, Week 48
Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best). (Per SAP Version 2.0 Appendix 10.9 for US Only)
Baseline, Week 48
Change From Baseline in BCVA (Region-specific Analysis) in the Study Eye at Week 60
Time Frame: Baseline, Week 60
Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best).
Baseline, Week 60
Assessment of Immunogenicity to Aflibercept by Measuring the Incidence of Treatment-emergent Anti-drug Antibodies (ADA) Response Through Week 96
Time Frame: Through Week 96
Number of participants with pre-existing immunoreactivity and treatment-emergent ADA response reported
Through Week 96
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Through Week 96
Time Frame: Through Week 96
A TEAE is an AE starting after the first dose of study drug to the last dose of study drug (active or sham) plus 30 days. Additionally, for patients who are still participating in the study (ie, have not been withdrawn and are continuing in the extension phase of the study) as of the week 96 visit all AEs up through the date of the week 96 visit were considered treatment-emergent.
Through Week 96
Number of Participants With Any Serious TEAE Through Week 96
Time Frame: Through Week 96
A TEAE is an AE starting after the first dose of study drug to the last dose of study drug (active or sham) plus 30 days. Additionally, for patients who are still participating in the study (ie, have not been withdrawn and are continuing in the extension phase of the study) as of the week 96 visit all AEs up through the date of the week 96 visit were considered treatment-emergent.
Through Week 96
Number of Participants With Any TEAE Through Week 156
Time Frame: Through Week 156
TEAEs are defined as AEs starting after the first dose of study drug to the last dose of study drug (active or sham) plus 30 days or week 156 visit, whichever was later.
Through Week 156
Number of Participants With Any Serious TEAE Through Week 156
Time Frame: Through Week 156
Through Week 156

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Regeneron Pharmaceuticals

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bayer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 29, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 18, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VGFTe-HD-DME-1934
  • 2019-003643-30 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication.

IPD Sharing Time Frame

Individual de-identified participant data will be made available once the indication has been approved by a regulatory body, if there is participant consent and there is not a reasonable likelihood of participant re-identification.

IPD Sharing Access Criteria

Qualified researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan) that support the methods and findings reported in a manuscript. Individual de-identified participant data will be made available once the indication has been approved by a regulatory body, if there is participant consent and there is not a reasonable likelihood of participant re-identification.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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