A Safety and Efficacy Trial of a Treat and Extend Protocol Using Ranibizumab With and Without Laser Photocoagulation for Diabetic Macular Edema

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Palmetto Retina Center, LLC
Study ID
NCT01934556
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this research study is to determine if a "Treat and Extend" regimen (increasing the time between visits when the disease is stable and not getting worse) of Ranibizumab 0.3 mg injections inside the eye is safe and effective at treating patients with swelling of the retina from diabetes.

Key Dates

First listed
Sep 4, 2013
Start date
Nov 30, 2013
Status verified
Oct 2020
Primary completion
Apr 30, 2017
Completion
Apr 30, 2018

Study Design

Enrollment
150 participants (actual)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Monthly
    Monthly Cohort (30 eyes) - Study eyes will receive intravitreal injections of 0.3 mg ranibizumab every 4 weeks for 24 months.
  • Active Comparator: TREX
    (60 eyes) - Monthly intravitreal injections of 0.3 mg ranibizumab for four visits. At the fourth visit (Week 12), if the central foveal thickness is ≤ 325 μm then the eye will receive 0.3 mg ranibizumab and begin the extension phase of the study. For all subsequent visits in the extension phase, appropriate changes to the treatment interval with 0.3 mg ranibizumab (i.e. extend, maintain, reduce) will be made based on pre-specified SD (Spectral Domain)-OCT criteria. Treatment is rendered at every visit. The time between visits is individualized based on each subject's response to treatment. If the central foveal thickness is \> 325 μm at week 12, then the patient will continue to receive monthly intravitreal injections of 0.3 mg ranibizumab until the central foveal thickness is ≤ 325 μm. Once the central foveal thickness is ≤ 325 μm, then the study eye will begin the extension phase of the study.
  • Active Comparator: GILA
    (60 eyes) - Monthly intravitreal injections of 0.3 mg ranibizumab for four visits combined with guided laser photocoagulation to all microaneurysms in the area of DME at visit 2 (Week 4) and then again every 3 months, if leakage is present on fluorescein angiography. If the central foveal thickness is ≤ 325 μm at visit 4 (Week 12), eyes will receive 0.3 mg ranibizumab and the extension phase will begin. For all subsequent visits in the extension phase, appropriate changes to the treatment interval with 0.3 mg ranibizumab (i.e. extend, maintain, reduce) will be made based on pre-specified SD-Optical coherence tomography criteria. If the central foveal thickness is \> 325 μm at week 12, then the patient will continue to receive monthly intravitreal injections of 0.3 mg ranibizumab and possible guided laser every 3 months until the central foveal thickness is ≤ 325 μm. Once the central foveal thickness is ≤ 325 μm, then the study eye will begin the extension phase of the study.

Primary Outcome Measure

Mean Change in Vision at 24 Months [ Time Frame: 2 Years ]

Locations (3)

FacilityCityStateZIPSite coordinators
Retina-Vitreous Associates Medical GroupBeverly HillsCalifornia90211-
Palmetto Retina CenterWest ColumbiaSouth Carolina29169-
Retina Consultants of HoustonHoustonTexas77030-

Find similar trials in Beverly Hills, CA

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Retina-Vitreous Associates Medical Group· Beverly Hills, CAPalmetto Retina Center· West Columbia, SCRetina Consultants of Houston· Houston, TX

Related Studies