Prevention of Macular Edema In Patients With Diabetic Retinopathy Undergoing Cataract Surgery (PROMISE)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
|Official Title:||Prevention of Macular Edema In Patients With Diabetic Retinopathy Undergoing Cataract Surgery|
- Safety and Efficacy [ Time Frame: Day 90 ] [ Designated as safety issue: Yes ]Incidence and severity of ocular and non-ocular adverse events (AEs) and serious AEs between treatment arms.
- Visual Acuity [ Time Frame: Day 90 ] [ Designated as safety issue: No ]Change from baseline in best-corrected visual acuity (BCVA) score at Day 90 as measured by ETDRS (early treatment diabetic retinopathy study)
- Macular Edema [ Time Frame: Day 90 ] [ Designated as safety issue: No ]Macular edema as measured by SD-OCT (spectral domain ocular coherence tomography)at 90 days
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Sham Comparator: Sham Injection
Patients will be sequentially randomized to treatment with a "sham" injection at the time of surgery. The sham injection is accomplished by pressing an empty syringe against the eye wall without penetration. This will be administered post cataract excision by the Prinicipal Investigator. The patient will be masked as to which Arm they are assigned.
Sham injection. No actual injection. No medication is used.
Other Name: Sham
Active Comparator: Intravitreal Aflibercept Injection
Patients will be sequentially randomized to treatment with Aflibercept 2 mg via intravitreal injection (0.05 mL or 50 microliters) at the time of surgery. This will be administered post cataract excision by the Principal Investigator. The patient will be masked as to which Arm they are assigned.
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.
Other Name: Eylea
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01988246
|Contact: Rishi Singh, M.D.||firstname.lastname@example.org|
|Contact: Kathi Dastoli, RN,CCRC||216-445-5248||DASTOLK@ccf.org|
|United States, Ohio|
|Cole Eye Institute, Cleveland Clinic||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Rishi Singh, M.D. 216-445-9497 email@example.com|
|Contact: Kathi Dastoli, RN,CCRC 216-445-5248 DASTOLK@ccf.org|
|Principal Investigator: Rishi Singh, M.D.|
|Principal Investigator:||Rishi Singh, M.D.||Cole Eye Institute, Cleveland Clinic|