Comparative Study of Dexamethasone Implant to Intravitreal Aflibercept in Subjects With Diabetic Macular Edema

Part of paid clinical trials in Houston, Texas.

Sponsor
The Cleveland Clinic
Study ID
NCT04411693
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Dexamethasone implant — DRUG
    A sustained-release drug delivery system containing 0.7 mg of Dexamethasone. Implant is administered by intravitreal injection.
  • Aflibercept — DRUG
    A single dose, 2mg, drug administered by intravitreal injection.

Study Details

This study is an interventional, prospective randomized study comparing the dexamethasone implant to intravitreal aflibercept. Subjects will have an initial single injection of aflibercept and will be randomized if diabetic macular edema persists. Each subject will be evaluated for 6 months following randomization. Thus, the study duration will be 12 months plus the recruitment period. Subjects will be evaluated every month for safety, efficacy as measured by SDOCT and best corrected visual acuity (BCVA) using the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) protocol. In addition, ultra-widefield angiography will be performed at run-in visit, baseline, month 3, and month 6.

Key Dates

Start date
Apr 10, 2020
Status verified
Jun 2024
Primary completion
Jan 31, 2024
Completion
Jan 31, 2024

Study Design

Enrollment
23 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group A: Intravitreal Dexamethasone Implant
    Subjects in this arm will be given intravitreal Dexamethasone implant injection at month 0. PRN intravitreal Dexamethasone implant injections will be given for persistent edema, if it has been 10 weeks or more since last implant injection. If it has been less than 10 weeks since last implant injection, subjects will receive PRN intravitreal Aflibercept for persistent edema.
  • Active Comparator: Group B: Intravitreal Aflibercept
    Subjects in this arm will be given Intravitreal aflibercept at month 0. PRN intravitreal Aflibercept will be given at months 1-6 for persistent edema.

Primary Outcome Measure

The mean change in central subfield thickness [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Retina Consultants of HoustonHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Retina Consultants of Houston· Houston, TX

Related Studies