Ranibizumab 0.5mg and 2.0mg to Treat Diabetic Macular Edema in Patients With Poor Response to Bevacizumab

Part of paid clinical trials in Bakersfield, California.

Sponsor
California Retina Consultants
Study ID
NCT01292798
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ranibizumab — DRUG
    0.05ml of 0.5mg or 2.0mg ranibizumab injected intravitreally

Study Details

This is an open-label, Phase I/II study of intravitreally administered ranibizumab either 0.5-mg and/or 2.0-mg in subjects with clinical, angiographic, and ocular coherence tomography (OCT) evidence of diabetic retinopathy with associated diabetic macular edema following bevacizumab therapy. Thirty patients will be enrolled in this study. Consented, enrolled subjects will receive multiple open-label intravitreal injections of 0.5 mg ranibizumab administered every 30 days (±7 days) for 3 injections during the mandatory treatment phase (Day 0, Month 1, and Month 2). Subjects with complete resolution of diabetic macular edema after 3 intravitreal injections of 0.5 mg ranibizumab will be treated as necessary with 0.5 mg ranibizumab to treat recurrent macular edema for an additional 9 months (12 months from Day 0). The intent is to administer additional ranibizumab treatment if there is evidence of disease activity documented on OCT (e.g., intra-retinal fluid, subretinal fluid and/or cystic changes). Subjects with residual diabetic macular edema following 3 intravitreal injections of 0.5 mg ranibizumab will be receive 3 intravitreal injections of 2.0 mg ranibizumab administered every 30 days (±7 days) for 3 injections at the Month 3, Month 4, and Month 5 study visits. Beginning at the Month 6 study visit, subjects with complete resolution of diabetic macular edema following 3 intravitreal injections of 2.0 mg ranibizumab will treated as necessary with 2.0 mg ranibizumab injections only to treat recurrent macular edema for an additional 6 months (12 months from Day 0). Subjects with residual diabetic macular edema following 3 consecutive intravitreal injections of 2.0 mg ranibizumab will be treated as necessary with 2.0 mg ranibizumab to treat persistent or recurrent macular edema for an additional 6 months (12 months from Day 0). Focal photocoagulation or intravitreal triamcinolone may be administered at the physician's discretion as an adjunct to ranibizumab injections beginning at Month 6 through Month 12 of the study. All subjects will make monthly visits for 12 months for evaluation of safety and efficacy. All subjects will have their first injection of ranibizumab on Day 0 and undergo a safety visit one week (±2 days) after the first injection. At subsequent visits, the subject will have a safety evaluation at the monthly scheduled follow-up visit prior to any intravitreal injection. Subjects will be contacted by the site personnel 1-2 days after each injection to elicit reports of decreased vision or pain or unusual new ocular symptoms in the study eye.

Key Dates

First listed
Feb 10, 2011
Start date
Mar 31, 2011
Status verified
Mar 2016
Primary completion
Apr 30, 2013
Completion
Apr 30, 2013

Study Design

Enrollment
43 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 0.5mg and 2.0mgRanibizumab
    Three consecutive intravitreal ranibizumab 0.5mg injections followed by three consecutive intravitreal ranibizumab 2.0mg injections if specific criteria is met.

Primary Outcome Measure

Overall Mean Change in Visual Acuity Scores at Month 6 Compared to Baseline [ Time Frame: baseline and 6 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
California Retina ConsultantsBakersfieldCalifornia93309-
California Retina ConsultantsOxnardCalifornia93030-
California Retina ConsultantsSanta BarbaraCalifornia93103-
California Retina ConsultantsSanta MariaCalifornia93454-
Retina Institute of Hawai'iHonoluluHawaii69815-

Find similar trials in Bakersfield, CA

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
California Retina Consultants· Bakersfield, CACalifornia Retina Consultants· Oxnard, CACalifornia Retina Consultants· Santa Barbara, CACalifornia Retina Consultants· Santa Maria, CARetina Institute of Hawai'i· Honolulu, HI

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