Treatment for CI-DME in Eyes With Very Good VA Study

Summary

Although multiple studies have clearly demonstrated that ranibizumab therapy is more effective than laser alone for vision gain and avoiding vision loss in patients with central-involved Diabetic Macular Edema (DME), only eyes with poor visual acuity, such as a visual acuity letter score of 78 or worse (approximate Snellen equivalent of 20/32 or worse) were eligible. Eyes that have central-involved DME with "good" visual acuity (20/25 or better) have not been addressed systematically by recent studies for treatment of DME. Baseline cohort characteristics from the Early Treatment Diabetic Retinopathy Study (ETDRS) suggest that a substantial percentage of eyes with central-involved DME may retain good vision. The investigators do not know definitively whether eyes with central-involved DME and good vision do better with anti-VEGF (vascular endothelial growth factor) (e.g. aflibercept) therapy initially, or focal/grid laser treatment or observation initially followed by anti-VEGF only if vision worsens.

The primary objective of the protocol is to compare the % of eyes that have lost at least 5 letters of visual acuity at 2 years compared with baseline mean visual acuity in eyes with central-involved DME and good visual acuity defined as a Snellen equivalent of 20/25 or better (electronic-ETDRS letter score of 79 or better) that receive (1) prompt focal/grid photocoagulation + deferred anti-VEGF, (2) observation + deferred anti-VEGF, or (3) prompt anti-VEGF.

Secondary objectives include:

* Comparing other visual acuity outcomes between treatment groups, such as the percent of eyes with at least 5, 10 and 15 letter losses in visual acuity from baseline mean visual acuity, percent of eyes with at least 5 letter gain in visual acuity from baseline, mean visual acuity, mean change in visual acuity, adjusted for baseline mean visual acuity
* For eyes randomized to deferred anti-VEGF, the percentage of eyes needing anti-VEGF treatment
* Comparing optical coherence tomography (OCT) outcomes, such as the mean change in OCT central subfield (CSF) thickness, adjusted for baseline mean thickness
* Comparing the number of eyes with PDR at randomization, proportion of eyes avoiding vitreous hemorrhage or panretinal photocoagulation (PRP) or vitrectomy for PDR between treatment groups
* Comparing safety outcomes between treatment groups
* Comparing associated treatment and follow-up exam costs between treatment groups

Conditions

• Diabetic Macular Edema

Interventions

PROCEDURE

Prompt Laser

Focal/grid laser performed at baseline and as needed during follow-up

DRUG

Prompt aflibercept

Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria

PROCEDURE

Deferred laser

Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met

DRUG

Deferred aflibercept

Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria

Sponsors & Collaborators

• Regeneron Pharmaceuticals

  collaborator INDUSTRY

• National Eye Institute (NEI)

  collaborator NIH

• National Institutes of Health (NIH)

  collaborator NIH

• Jaeb Center for Health Research

  lead OTHER

Principal Investigators

• Carl Baker, MD · Paducah Retina Center

• Adam Glassman, MS · Jaeb Center for Health Research

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-10-31

Primary Completion

2018-09-11

Completion

2018-09-11

Countries

• United States
• Canada

Study Locations