Ranibizumab and Peripheral Scatter Laser in Patients With Diabetic Macular Edema and Peripheral Nonperfusion

Part of paid clinical trials in Tampa, Florida.

Sponsor
Retina Associates of Florida, P.A.
Study ID
NCT00815360
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • intravitreal injection of ranibizumab — DRUG
    intravitreal injection of 0.5 mg ranibizumab
  • peripheral laser — PROCEDURE
    ultra-widefield fluorescein angiography guided peripheral laser
  • intravitreal injection of triamcinolone acetonide — DRUG
    intravitreal injection of 4.0 mg triamcinolone acetonide
  • macular laser — PROCEDURE
    macular laser to areas of retinal thickening or leakage

Study Details

To investigate the role of ranibizumab and angiographically-directed peripheral scatter laser therapy in patients with clinically-significant diabetic macular edema (CSME) and peripheral nonperfusion. We propose a novel treatment of CSME in a subgroup of patients defined by a combination of ultrawide-field angiography (UWFA) and optical coherence tomography (OCT). Within this classification scheme, patients with CSME are subdivided by the presence of: 1) focal macular leakage, 2) vitreomacular interface traction, and/or 3) peripheral nonperfusion. The successful treatment of diabetic macular edema would be dictated by pathophysiology-directed therapy based on this classification. The subgroup of interest for this clinical trial is characterized by diabetic macular edema, peripheral nonperfusion on UWFA, and the absence of macular traction on OCT. This group of patients has previously not been well recognized or characterized due to limitations in previous, standard angiographic evaluation of the retinal periphery. We postulate that this subcategory represents one with a high rate of failure of accepted therapies given persistence of the basic pathophysiologic mechanism for CSME, namely ischemia-induced production of Vascular Endothelial Growth Factor (VEGF) from the retinal periphery. This also represents a population of patients with likely recurrence of CSME despite treatment with anti-VEGF therapy alone for the same reason.

Key Dates

First listed
Dec 30, 2008
Start date
Feb 29, 2008
Status verified
Oct 2014
Primary completion
Jul 31, 2011
Completion
Aug 31, 2011

Study Design

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

Arms

  • Experimental: Treatment group
    1. single intravitreal injection of ranibizumab (0.5 mg in 0.1 cc) 2. peripheral laser to areas of retinal nonperfusion on ultra-widefield fluorescein angiography
  • Active Comparator: Control Group
    1. single intravitreal injection of triamcinolone acetonide (4.0 mg in 0.1 cc) 2. macular laser per treatment criteria

Primary Outcome Measure

Mean Change in Best Corrected Visual Acuity (BCVA), as Assessed by the Number of Letters Read Correctly on the ETDRS Eye Chart at a Starting Test Distance of 4 Meters From Baseline to Month 6. [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Retina Associates of FloridaTampaFlorida33609-

Find similar trials in Tampa, FL

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Retina Associates of Florida· Tampa, FL

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