Treatment for CI-DME in Eyes With Very Good VA Study
Status:
Completed
Trial end date:
2018-09-11
Target enrollment:
Participant gender:
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
Phase:
Phase 3
Details
Lead Sponsor:
Jaeb Center for Health Research
Collaborators:
National Eye Institute (NEI) National Institutes of Health (NIH) Regeneron Pharmaceuticals