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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT00473330
Date of registration: 13/05/2007
Prospective Registration: Yes
Primary sponsor: Genentech, Inc.
Public title: A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema (ME) With Center Involvement Secondary to Diabetes Mellitus (RISE) RISE
Scientific title: A Phase III, Double-masked, Multicenter, Randomized, Sham Injection-controlled Study of the Efficacy and Safety of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema With Center Involvement Secondary to Diabetes Mellitus
Date of first enrolment: June 2007
Target sample size: 377
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00473330
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).  
Phase:  Phase 3
Countries of recruitment
United States
Contacts
Name:     Jason Ehrlich, M.D., Ph.D.
Address: 
Telephone:
Email:
Affiliation:  Genentech, Inc.
Key inclusion & exclusion 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 ┬Ám 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 the study, or renders the subject at high risk from treatment
complications.

- Pregnancy or lactation.

- History of allergy to fluorescein.

- History of allergy to ranibizumab injection or related molecule.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Diabetes Mellitus
Macular Edema
Intervention(s)
Drug: Ranibizumab
Drug: Sham injection
Primary Outcome(s)
Percentage of Patients Who Gained = 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24 [Time Frame: Baseline to Month 24]
Secondary Outcome(s)
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Months 24 and 36 in Patients With Focal Edema at Baseline [Time Frame: Baseline to Month 36]
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Months 24, 36, and 48 [Time Frame: Baseline to Month 48]
Mean Change From Baseline in Central Foveal Thickness at Months 24, 36, and 48 [Time Frame: Baseline to Month 48]
Mean Change From Month 36 in Best Corrected Visual Acuity (BCVA) Score in the Study Eye at Month 48 [Time Frame: Month 36 to Month 48]
Mean Change From Month 36 in Central Foveal Thickness in the Study Eye at Month 48 [Time Frame: Month 36 to Month 48]
Mean Number of Macular Laser Treatments From Baseline Through Months 24 and 36 [Time Frame: Baseline to Month 36]
Percentage of Patients Who Gained = 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Months 36 and 48 [Time Frame: Baseline to Month 48]
Percentage of Patients Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Months 24, 36, and 48 [Time Frame: Baseline to Month 48]
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 [Time Frame: Month 36 to Month 48]
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 [Time Frame: Baseline to Month 36]
Percentage of Patients With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better at Months 24, 36, and 48 [Time Frame: Months 24, 36, and 48]
Percentage of Patients With Resolution of Leakage at Month 24 [Time Frame: Baseline to Month 24]
Secondary ID(s)
FVF4170g
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 17/01/2013
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00473330
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