Evaluation of the Retina in Patients With Non-proliferative Diabetic Retinopathy After Aflibercept Injection in the Eye

Conditions

• Retinopathy, Diabetic

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Aflibercept Injection — DRUG
  Patients randomized to Arm A will receive 2 mg IVT aflibercept injections every 4 weeks (Q4W) to Week 20, followed by 2-mg aflibercept injections Q8W to Week 52.
• Sham injection — DRUG
  Patients randomized to Arm B will receive sham intravitreal injections every 4 weeks (Q4W) to Week 20, followed by sham intravitreal injections Q8W to Week 52. Sham means eye will be numbed and a syringe with no needle will be touched to the eye.

Study Details

The purpose of this study is to specifically assess the effect of intravitreal aflibercept injections on the health of cells and the flow of blood through the retinal blood vessels by using advanced technology called adaptive optics.

Key Dates

Start date

Feb 1, 2021

Status verified

Apr 2021

Primary completion

Feb 1, 2024

Completion

Feb 1, 2024

Study Design

Enrollment

0 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Aflibercept injection
  Intravitreal injection of Aflibercept
• Placebo Comparator: Sham injection
  Empty syringe with no needle

Primary Outcome Measure

Mean change in photoreceptor mosaic [ Time Frame: baseline to 52 weeks ]

Locations (1)

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