Prevention of Macular Edema In Patients With Diabetic Retinopathy Undergoing Cataract Surgery (PROMISE)
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|ClinicalTrials.gov Identifier: NCT01988246|
Recruitment Status : Completed
First Posted : November 20, 2013
Results First Posted : May 22, 2020
Last Update Posted : May 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Retinopathy||Drug: Aflibercept Drug: Sham||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Prevention of Macular Edema In Patients With Diabetic Retinopathy Undergoing Cataract Surgery|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||April 25, 2018|
|Actual Study Completion Date :||January 14, 2020|
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.
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
- Number of Participants With Ocular and Non-Ocular Adverse Events [ Time Frame: Day 90 ]Number of participants with ocular and non-ocular adverse events (AEs) in both treatment arms.
- Change From Baseline in Best-Corrected Visual Acuity (BCVA) Score [ Time Frame: Day 90 ]Change from baseline in best-corrected visual acuity (BCVA) score and BCVA score at Day 90 as measured by ETDRS (early treatment diabetic retinopathy study) There were no sub scales used. These are common methods for ophthalmology studies to report their findings. The scale provided is the Electronic-Early Treatment in Diabetic Retinopathy Scale (E-ETDRS) best corrected visual acuity scale. Values that are higher are considered better and values that are lower are considered worse. Minimum E-ETDRS was 24 E-ETDRS letters and maximum E-ETDRS was 80 E-ETDRS letters.
- Change From Baseline in Retinal Thickness [ Time Frame: Day 90 ]The change in macular edema as measured by SD-OCT (spectral domain ocular coherence tomography)at 90 days
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01988246
|United States, Ohio|
|Cole Eye Institute, Cleveland Clinic|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Rishi Singh, M.D.||Cole Eye Institute, Cleveland Clinic|