Long-Term Efficacy and Safety of Intravitreal Aflibercept Injections for the Treatment of Diabetic Retinopathy for Subjects Who Completed the 2-Year PANORAMA Trial (VOYAGE)

August 17, 2023 updated by: Greater Houston Retina Research
The VOYAGE trial will assess diabetic retinopathy severity scale (DRSS) levels, through 112 weeks, while being managed with aflibercept as needed, among subjects who completed the 2-year PANORAMA trial (VGFTe-OD-1411) and were treated in a clinical setting prior to joining the VOYAGE study.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This phase 4 study is designed to assess the need for ongoing 2 mg intravitreal aflibercept injections (IAI) for subjects who completed the 2-year PANORAMA (VGFTe-OD-1411) trial for the management of diabetic retinopathy (DR). Sites will be considered for VOYAGE if they have 4 or more subjects from PANORAMA able to participate.

Relevant data from all participating subjects will be collected and reported retrospectively for the period between PANORAMA study exit and VOYAGE study enrollment.

For the prospective portion of the study, eyes will be assigned to 1 of 2 groups, eyes without panretinal photocoagulation (PRP) and eyes with PRP.

Group 1: Subjects with study eyes without PRP will be seen every 16 weeks (Q16W) and treated with IAI on a flexible treatment regimen based on their DRSS level. An injection will be given at each 16-week visit when the DRSS level is 47 or worse. If the DRSS level is better than 47, for example level 43 or 35, the study eye will not be treated. DRSS level will be determined by the investigator, based on ophthalmic exam and fundus photography (FP) compared to prior imaging when available.

Every 8 week visits can be performed under specific circumstances:

  • If a subject has a 2-step DRSS level worsening compared to the last protocol-scheduled 16-week visit (for example the week-16 or week-32 visit) and/or the DRSS level is 53 or worse OR
  • If a subject has active proliferative DR (PDR)

Under both of these circumstances, IAI will be administered as scheduled and the subject can be seen and treated every 8 weeks (Q8W) with IAI. Under both of these circumstances, Q8W visits and Q8W IAI treatments can be continued until there is no active PDR and the DRSS improves to the level observed at the visit before the subject began being seen at 8-week intervals.

Group 2: Subjects with study eyes with PRP will be seen Q16W and treated with IAI on a flexible treatment regimen based on activity of the neovascular disease process as assessed by the treating investigator based on ophthalmic exam and/or FP compared to prior imaging when available. If the neovascular disease is inactive, no treatment will be given. If the neovascular disease is active and stable (not new or worse), the subject will be treated with intravitreal (IVT) IAI at the Q16W interval. If new or worsening neovascular disease develops, subjects may be seen and treated Q8W until the neovascular disease is stable or inactive at which time the interval between visits will increase to 16 weeks.

Subjects in both groups will be evaluated for efficacy, using best corrected visual acuity (BCVA) using the 4-meter ETDRS protocol with normal-luminance, Humphrey Visual Field (HVF), National Eye Institute (NEI) Visual Function Questionnaire (VFQ) 25, spectral domain optical coherence tomography (SD-OCT), optical coherence tomography angiography (OCT-A), FP, and fluorescein angiography (FA), and for ocular and systemic safety (including ophthalmic exams and laboratory assessments) through week 112.

Subjects who develop new or worsening PDR, including anterior segment neovascularization (ASNV), or center-involved DME may qualify for rescue treatment.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Puerto Rico
      • Arecibo, Puerto Rico, 00613
        • Emanuelli Research and Development Center, LLC
  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Retina Vitreous Associates Medical Group
    • Florida
      • Orlando, Florida, United States, 32806
        • Central Florida Retina Center
      • Winter Haven, Florida, United States, 33880
        • Center for Retina and Macular Disease
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Marietta Eye Clinic
    • Indiana
      • New Albany, Indiana, United States, 47150
        • John Kenyon American Eye Institute
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Cumberland Valley Retina Consultants, P.C.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Dean McGee Eye Institute
    • South Carolina
      • Florence, South Carolina, United States, 29501
        • Palmetto Retina Center, LLC - Florence
      • West Columbia, South Carolina, United States, 29169
        • Palmetto Retina Center
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Charles Retina Institute
    • Texas
      • Bellaire, Texas, United States, 77401
        • Retina Consultants of Texas
      • Harlingen, Texas, United States, 78550
        • Valley Retina Institute
      • Willow Park, Texas, United States, 76087
        • Strategic Clinical Research Group, LLC

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Enrolled and completed PANORAMA (VGFTe-OD-1411) clinical trial
  2. Willing and able to comply with clinic visits and study-related procedures
  3. Provide signed informed consent

Exclusion Criteria:

  1. Any prior systemic anti-vascular endothelial growth factor (VEGF) treatment or IVT anti-VEGF treatment in the study eye within 21 days of baseline
  2. Any intra- or periocular corticosteroid treatment in the study eye within 3 months of baseline
  3. Any intraocular sustained-release treatment, implantable device, or gene therapy in the study eye
  4. Pregnant or breastfeeding women

  5. Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening/baseline; intrauterine device (IUD); bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly).

    • Contraception is not required for men with documented vasectomy. **Postmenopausal women must be amenorrhoeic for at least 12 months in order not to be considered of childbearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1

Study eyes without PRP from the PANORAMA trial. Subjects will be evaluated every 16 weeks and treated if DRSS level is 47 or worse as determined by the treating investigator.

Subjects may be evaluated every 8 weeks if a 2-step DRSS level worsening compared to the last protocol-scheduled 16-week visit occurs, the DRSS level is 53 or worse, or if a subject has active PDR. Visits can continue every 8 weeks until there is no active PDR, and the DRSS improves to the level observed at the visit before the subject began being seen at 8-week intervals. Thereafter, visits will continue at 16 week intervals.
Drug: Aflibercept Injection
Intravitreal 2mg aflibercept injection
Other Names:
  • Eylea
Experimental: Group 2

Study eyes with PRP from the PANORAMA trial. Subjects will be evaluated every 16 weeks and treated if the neovascular disease process is active and stable (not new or worse) as determined by the treating investigator. If the neovascular disease is inactive, no treatment will be given.

If new or worsening neovascularization develops, subjects may be seen and treated every 8 weeks until the neovascular disease is stable or inactive, at which time the interval between visits will increase to 16 weeks.
Drug: Aflibercept Injection
Intravitreal 2mg aflibercept injection
Other Names:
  • Eylea

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DRSS Level Achievement in the VOYAGE study
Time Frame: 112 weeks
Proportion of subjects achieving a DRSS level of 43 or less in the VOYAGE study.
112 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DRSS Level Achievement in the PANORAMA study
Time Frame: 112 weeks
Proportion of subjects achieving a DRSS level of 43 or less from the completion of the PANORAMA study
112 weeks
DRSS Level Improvement
Time Frame: 112 weeks
Proportion of subjects with stable, worsened, or improved DRSS level from baseline to week 48 and baseline to week 112 compared to the DRSS at the baseline of the VOYAGE trial and the DRSS at the last visit of the PANORAMA trial.
112 weeks
Injection Frequency
Time Frame: 112 weeks
Mean and median number of IVT aflibercept injections (with and without IAI given for DME)
112 weeks
Subjects without Treatment
Time Frame: 112 weeks
Proportion of subjects receiving 0 injections
112 weeks
PDR Events
Time Frame: 112 weeks
Percentage of subjects over time who develop a new PDR event
112 weeks
Center-Involved Diabetic Macular Edema Development
Time Frame: 112 weeks
Percentage of subjects over time who develop center-involved (CI) DME
112 weeks
Change in Visual Acuity
Time Frame: 112 weeks
Mean change in ETDRS BCVA from baseline
112 weeks
Change in Central Retinal Thickness
Time Frame: 112 weeks
Mean change in central retinal thickness from baseline
112 weeks
Change in Area of Nonperfusion
Time Frame: 112 weeks
Change in total area of retinal capillary non-perfusion from baseline
112 weeks
Changes in Visual Function (HVF)
Time Frame: 112 weeks
Changes in visual function outcomes from Humphrey Visual Field from baseline
112 weeks
Changes in Visual Function
Time Frame: 112 weeks
Changes in visual function outcomes NEI VFQ-25 from baseline
112 weeks
Incidence of Adverse Events
Time Frame: 112 weeks
Incidence and severity of ocular and systemic adverse events from baseline
112 weeks

Collaborators and Investigators

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

Sponsor

Greater Houston Retina Research

Collaborators

Regeneron Pharmaceuticals
Clinical Trials Resource Group, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

June 1, 2021

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

January 6, 2021

First Submitted That Met QC Criteria

January 12, 2021

First Posted (Actual)

January 13, 2021

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 17, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VOYAGE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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