High Dose Eylea for Proliferative Diabetic Retinopathy Outcomes

Part of paid clinical trials in Austin, Texas.

Sponsor
Edward Wood, MD
Study ID
NCT07118670
Phase
PHASE4
Status
Active Not Recruiting

Conditions

  • Proliferative Diabetic Retinopathy (PDR)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this Phase 4 study is to evaluate the safety of aflibercept 8mg in patients with proliferative diabetic retinopathy without center-involved diabetic macular edema.

Key Dates

Start date
Dec 8, 2025
Status verified
Mar 2026
Primary completion
Feb 29, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: All subjects
    Subjects will receive 8mg aflibercept at week 0, 4, and 8. At week 12, subjects will enter a variable treatment and extension approach where they may be extended by 4-week intervals with no maximum interval between treatments until the end of study visit at week 96. Supplemental: Disease activity will be assessed at every 4-week visit and supplemental treatment with panretinal photocoagulation (PRP) as needed and/or intravitreal (IVT) 8mg aflibercept injections as determined by the regression patterns listed below. No regression: administer IVT aflibercept 8mg at 4-week intervals. If NV is not assessable due to VH, continue IVT and reassess; PRP is deferred. Supplemental PRP permitted ONLY if NV is assessable AND "No Regression" persists after prespecified treatment thresholds. Partial regression: Continue IVT aflibercept 8mg. Continue monthly observation. PRP not permitted. Total Regression: Without IVT aflibercept 8mg. Continue monthly observation. PRP not permitted.

Primary Outcome Measure

Primary Endpoint - DRSS step improvement [ Time Frame: Baseline through weeks 48 and 96 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Retina Consultants of Texas - Austin Retina AssociatesAustinTexas78705-
Retina Consultants of TexasBellaireTexas77401-
Retina Consultants of Texas - San AntonioSan AntonioTexas78240-

Find similar trials in Austin, TX

By research site
Retina Consultants of Texas - Austin Retina Associates· Austin, TXRetina Consultants of Texas· Bellaire, TXRetina Consultants of Texas - San Antonio· San Antonio, TX

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