Phase 3
N=382
A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema (ME) With Center Involvement Secondary to Diabetes Mellitus (RIDE)
Diabetes Mellitus · Macular Edema
Bottom Line
View on ClinicalTrials.gov: NCT00473382 ↗Enrolled (actual)
382
Serious AEs
41.0%
Results posted
Jan 2013
Primary outcome: Primary: Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24 — 33.6; 45.7; 12.3 Percentage of patients — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ranibizumab (Drug); Sham injection (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Genentech, Inc.
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24 |
33.6; 45.7; 12.3 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Months 24, 36, and 48 |
10.9; 12.0; 2.3; NA; 10.6; 11.4 | <0.0001 sig |
| SECONDARY Percentage of Patients With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better at Months 24, 36, and 48 |
54.4; 62.2; 34.6; NA; 55.2; 59.1 | 0.0002 sig |
| SECONDARY Percentage of Patients Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Months 24, 36, and 48 |
98.4; 96.1; 91.5; NA; 96.8; 96.1 | 0.0119 sig |
| SECONDARY Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Months 24 and 36 in Patients With Focal Edema at Baseline |
10.5; 12.8; 1.9; NA; 10.8; 10.9 | 0.0102 sig |
| SECONDARY Mean Change From Baseline in Central Foveal Thickness at Months 24, 36, and 48 |
-259.8; -270.7; -125.8; NA; -261.8; -266.7 | <0.0001 sig |
| SECONDARY Percentage of Patients With a ≥ 3-step Worsening From Baseline in the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale Score for Eyes at Months 24 and 36 |
1.7; 0; 5.6; NA; 0.9; 0.8 | 0.0853 |
| SECONDARY Percentage of Patients With Resolution of Leakage at Month 24 |
17.1; 30.7; 2.3 | 0.0002 sig |
| SECONDARY Mean Number of Macular Laser Treatments From Baseline Through Months 24 and 36 |
0.7; 0.3; 1.6; NA; 0.9; 0.4 | <0.0001 sig |
| SECONDARY Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Months 36 and 48 |
36.8; 40.2; 19.2; 48.7; 41.0; 17.6 | — |
| SECONDARY Mean Change From Month 36 in Best Corrected Visual Acuity (BCVA) Score in the Study Eye at Month 48 |
-0.9; 0.3; -2.6 | — |
| SECONDARY Percentage of Patients Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score in the Study Eye From Month 36 at Month 48 |
92.3; 97.4; 88.2 | — |
| SECONDARY Mean Change From Month 36 in Central Foveal Thickness in the Study Eye at Month 48 |
46.1; 44.1; 9.6 | — |
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.
Eligibility Criteria
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, bevacizumab, ranibizumab, etc) within 3 months of the Day 0 (first day of treatment) visit.
- Proliferative diabetic retinopathy (PDR) in the study eye, with the exception of inactive, regressed PDR.
- Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in the study eye.
Concurrent Ocular Conditions
- Vitreomacular traction or epiretinal membrane in the study eye.
- Ocular inflammation (including trace or above) in the study eye.
- History of idiopathic or autoimmune uveitis in either eye.
- Structural damage to the center of the macula in the study eye that is likely to preclude improvement in VA following the resolution of macular edema, including atrophy of the retinal pigment epithelium (RPE), subretinal fibrosis, or organized hard-exudate plaque.
- Ocular disorders in the study eye that may confound interpretation of study results, including retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization (CNV) of any cause (eg, age-related macular degeneration (AMD), ocular histoplasmosis, or pathologic myopia).
- Concurrent disease in the study eye that would compromise visual acuity or require medical or surgical intervention during the study period.
- Cataract surgery in the study eye within 3 months, yttrium-aluminum-garnet (YAG) laser capsulotomy within the past 2 months, or any other intraocular surgery within the 90 days preceding Day 0.
- Aphakia or absence of the posterior capsule in the study eye.
- Uncontrolled glaucoma or previous filtration surgery in the study eye.
- Spherical equivalent of the refractive error in the study eye of more than -8 diopters myopia.
- Evidence at examination of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye or current treatment for serious systemic infection.
- Uncontrolled blood pressure.
- History of cerebral vascular accident or myocardial infarction within 3 months prior to Day 0.
- Uncontrolled diabetes mellitus.
- Renal failure requiring dialysis or renal transplant.
- Participation in an investigational trial within 30 days prior to screening that involved treatment with any drug (excluding vitamins and minerals) or device.
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug, might affect interpretation of the results of
Data sourced from ClinicalTrials.gov (NCT00473382). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.