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Prevention of Macular Edema In Patients With Diabetic Retinopathy Undergoing Cataract Surgery

NCT01988246 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-05-22

Study results available
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Summary

To determine the safety and efficacy of intravitreal Aflibercept (Eylea) injection in patients with diabetic retinopathy in the prevention of macular edema following cataract surgery.

Conditions

Interventions

DRUG

Aflibercept

Patients will be assigned to treatment with 2 mg intravitreal Aflibercept injection (0.05 mL or 50 microliters) administered at the time of surgery (post cataract excision) or sham injection.

DRUG

Sham

Sham injection. No actual injection. No medication is used.

Sponsors & Collaborators

Principal Investigators

  • Rishi Singh, M.D. · Cole Eye Institute, Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2018-04-25
Completion
2020-01-14

Countries

  • United States

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01988246 on ClinicalTrials.gov