NCT01988246

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Rishi Singh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Diabetic retinopathy patients who are at risk of developing macular edema (defined as ≥ 30 % increase from pre-operative baseline in central subfield macular thickness) within 90 days following cataract surgery. Diabetic patients are defined as those who have either Type 1 or Type 2 diabetes. The patients must have either mild, moderate, or severe non proliferative retinopathy or treated proliferative retinopathy. Patients must be 18 years of age and older, of any race and either sex, requiring cataract extraction with planned implantation of a posterior chamber intraocular lens into the lens capsule.

Conditions

• Diabetic Retinopathy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-12-01
• Primary completion: 2018-04-25
• Completion: 2020-01-14
• First posted: 2013-11-20
• Last updated: 2020-05-22
• Results posted: 2020-05-22

Locations

1 site across 1 country: United States