Anti-VEGF Therapy Versus Dexamethasone Implant for DME

June 25, 2019 updated by: Aditya Sudhalkar, Sudhalkar Eye Hospital

Anti-VEGF Therapy Versus Dexamethasone Implant for Treatment Naive Diabetic Macular Edema: A Randomized Controlled Trial

We look at a randomized comparative study of 2 FDA approved anti-VEGF agents(aflibercept and ranibizumab) and see how they compare against the dexamethasone implant for phakic as well as pseudophakic eyes with treatment naive diabetic macular edema in terms of efficacy and safety over two years.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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.

Detailed Description

A randomized, partially masked, observational/interventional trial looking at the efficacy and safety of 2 FDA approved anti-VEGF agents vis-a-vis the dexamethasone implant as primary therapy for treatment naive diabetic macular edema in phakic as well as pseudophakic patients.

Patients with treatment naive clinically significant macular edema will be randomized to receive one of the aforementioned therapies in a 1:1:1 distribution. Primary inclusion criteria are :

Well controlled diabetes(HbA1c<7%) and co-morbidities. Central Subfield Thickness of 300 microns or greater BCVA < or equal to 6/12.

Exclusion Criteria:

Contraindications to the aforementioned drugs Confounding Ocular co-morbidities that can affect visual assessment(except Cataract Grade II or less as per the LOCS III classification) Refusal for enrolment

A comprehensive ocular and systemic examination will be performed along with fundus fluorescein angiography, optical coherence tomography and intraocular pressure measurements with the Goldmann Applanation Tonometer. The BCVA will be recorded using Snellen's chart

Intravitreal injections will be administered using a standardized technique and under strict asepsis. No postoperative antibiotics will be given.

Patients will be followed on postoperative days 1, 7 and then monthly for 2 years.

At each visit, the BCVA, IOP, ocular exam and OCT scans will be performed at each visit.

Patients will be treated as per the guidelines laid out for the treat and extend study. For the dexamethasone implant, re-injections will be allowed first 3 months after the first injection.

Switch therapy is permissible for anti-VEGF agents after 6 months; first to the other anti-VEGF(for 6 more injections) and then to the dexamethasone implant. Rescue Laser therapy is as per physician's description.

Primary outcome measure: The BCVA in each group from baseline to final follow-up at 2 years.

Secondary outcome measure: Change in CST from baseline to years, the number of injections required per group and the complications, if any.

Statistical Analysis will include demographic descriptions, the Shapiro Wilk test to look for normality of distribution, multiple measures ANOVA test, Fisher's exact test, Chi-Square test and paired and unpaired t-test wherever appropriate.

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 (Anticipated)

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.
150

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 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 Locations

  • Germany
    • Bremen
      • Bremerhaven, Bremen, Germany, 27568
        • Alphavision Augenzentrum
        • Contact:
          • Alper Bilgic, MS
          • Phone Number: +491731505937
        • Contact:
          • Aditya Sudhalkar, MS
          • Phone Number: +919909917561

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Well controlled diabetes(HbA1c<7%) and co-morbidities. Central Subfield Thickness of 300 microns or greater BCVA < or equal to 6/12.

Exclusion Criteria:

  • Contraindications to the aforementioned drugs Confounding Ocular co-morbidities that can affect visual assessment(except Cataract Grade II or less as per the LOCS III classification) Macular ischemia or proliferative Disease Refusal for enrolment

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: Double

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: Group 1
Aflibercept intravitreal injection for CSME
Drug: Aflibercept,
Primary therapy will be with Aflibercept. If the edema does not respond to the intervention, the patient will be treated with Ranibizumab, Dexamethasone Implant or Laser.
Other Names:
  • Ranibizumab
  • Dexamethasone Implant, Laser
Other: Group 2
Ranibizumab Intravitreal Injection for CSME
Drug: Ranibizumab Injection
Primary therapy will be with ranibizumab. If the edema does not respond to the intervention, the patient will be treated with Alfibercept, Dexamethasone Implant or Laser.
Other Names:
  • Dexamethasone Implant, Aflibercept, Laser
Experimental: Group 3
Dexamethasone Implant for CSME
Drug: Ozurdex Drug Implant Product
Primary therapy will be with Ozurdex. If the edema does not respond to the intervention, the patient will be treated with Alfibercept, Ranibizumab or Laser

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
Best Corrected Visual Acuity
Time Frame: 2 years
BCVA measured at baseline and final follow-up
2 years

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
Central Subfield Thickness
Time Frame: 2 years
Change in CST over 2 years
2 years
Complications
Time Frame: 2 years
Complications in each group
2 years
Injection Count
Time Frame: 2 years
Number of injections in each group
2 years

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.
Sudhalkar Eye Hospital

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 (Anticipated)

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 25, 2019

Primary Completion (Anticipated)

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.
June 24, 2021

Study Completion (Anticipated)

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 24, 2023

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).
June 24, 2019

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 25, 2019

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 26, 2019

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.
June 26, 2019

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.
June 25, 2019

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.
June 1, 2019

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.
  • SudhalkarEH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All details of FFA, OCT, BCVA and IOP

IPD Sharing Time Frame

Upon completion of study

IPD Sharing Access Criteria

Will be provided only to Ophthalmologists

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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