A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema (ME) With … (NCT00473382) | Clinical Trial Compass
CompletedPhase 3
A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema (ME) With Center Involvement Secondary to Diabetes Mellitus (RIDE)
382 participantsStarted 2007-06
Plain-language summary
This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study of the efficacy and safety of ranibizumab injection in patients with clinically significant macular edema with center involvement (CSME-CI) secondary to diabetes mellitus (Type 1 or 2). This study is identical in design to study NCT00473330 (Protocol ID FVF4170g).
The open-label extension phase of the study was stopped after receiving FDA approval of the study drug (ranibizumab) for diabetic macular edema.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Willingness to provide written informed consent and, at U.S. sites, Health Insurance Portability and Accountability Act (HIPAA) authorization, and in other countries, as applicable according to national laws.
* Age ≥ 18 years.
* Diabetes mellitus (Type 1 or 2) .
* Retinal thickening secondary to diabetes mellitus (DME) involving the center of the fovea with central macular thickness ≥ 275 µm in the center subfield as assessed on optical coherence tomography (OCT).
* Best corrected visual acuity (BCVA) score in the study eye of 20/40 to 20/320 approximate Snellen equivalent using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at an initial testing distance of 4 meters.
* Decrease in vision determined to be primarily the result of DME and not to other causes.
* For sexually active women of childbearing potential, use of an appropriate form of contraception (or abstinence) for the duration of the study.
* Ability (in the opinion of the investigator) and willingness to return for all scheduled visits and assessments.
Exclusion Criteria:
* History of vitreoretinal surgery in the study eye.
* Panretinal photocoagulation (PRP) or macular laser photocoagulation in the study eye within 3 months of screening.
* Previous use of intraocular corticosteroids in the study eye (eg, triamcinolone acetonide \[TA\]) within 3 months of screening.
* Previous treatment with anti-angiogenic drugs in either eye (pegaptanib sodium, anecortave acetate, bevaciz…
What they're measuring
1
Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24