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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Rishi Singh
Study ID
NCT01988246
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aflibercept — DRUG
    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.
  • Sham — DRUG
    Sham injection. No actual injection. No medication is used.

Study Details

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.

Key Dates

Start date
Dec 31, 2013
Status verified
May 2020
Primary completion
Apr 25, 2018
Completion
Jan 14, 2020

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.
  • 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.

Primary Outcome Measure

Number of Participants With Ocular and Non-Ocular Adverse Events [ Time Frame: Day 90 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cole Eye Institute, Cleveland ClinicClevelandOhio44195-

Find similar trials in Cleveland, OH

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Cole Eye Institute, Cleveland Clinic· Cleveland, OH

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