Prevention of Macular Edema In Patients With Diabetic Retinopathy Undergoing Cataract Surgery (PROMISE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01988246|
Recruitment Status : Recruiting
First Posted : November 20, 2013
Last Update Posted : January 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Retinopathy||Drug: Aflibercept Drug: Sham||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Prevention of Macular Edema In Patients With Diabetic Retinopathy Undergoing Cataract Surgery|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||July 2018|
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
- Safety and Efficacy [ Time Frame: Day 90 ]Incidence and severity of ocular and non-ocular adverse events (AEs) and serious AEs between treatment arms.
- Visual Acuity [ Time Frame: Day 90 ]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 ]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
|Contact: Rishi Singh, M.D.||firstname.lastname@example.org|
|Contact: Diana C McOwen, RN, BSNemail@example.com|
|United States, Ohio|
|Cole Eye Institute, Cleveland Clinic||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Rishi Singh, M.D. 216-445-9497 firstname.lastname@example.org|
|Contact: Angela Borer, BS 216-445-7176 email@example.com|
|Principal Investigator: Rishi Singh, M.D.|
|Principal Investigator:||Rishi Singh, M.D.||Cole Eye Institute, Cleveland Clinic|