A Study Evaluating Dosing Regimens for Treatment With Intravitreal Ranibizumab Injections in Subjects With Macular Edema Following Retinal Vein Occlusion

NCT01277302 | Completed Phase 4 Results

• 2 other identifiers: FVF4967gML01296
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 42

Brief Summary

This was a Phase IV multicenter, randomized, open-label study, with masking of the vision examiner, of the efficacy and safety of intravitreal ranibizumab 0.5 mg in subjects with macular edema following Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO).

Conditions

Macular Edema

Outcome Measures

Primary Outcomes (1)

• Trend of Change From Baseline in the Best Corrected Visual Acuity (BCVA) Scores From Month 7 to Month 15

  BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement. The reported data are the observed changes from Baseline in BCVA at Months 7 and 15. For the statistical analysis, the interaction term of treatment by time in a longitudinal model was used to assess whether there was a difference in the trend of change from Baseline in the visual acuity scores from Month 7 to Month 15 between the 2 randomized treatment groups, Monthly and PRN.

  Baseline to Month 15

Secondary Outcomes (8)

• Visual Acuity Change From Previous Month During the Alternate Dose Regimen Period in Subjects Who Met the VA-OCT Stability Criteria at the Previous Month

  Month 7 through Month 15

• Percentage of Participants Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline

  Month 7 to Month 15

• Percentage of Participants With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better

  Month 7 to Month 15

• Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score

  Month 1 to Month 15

• Percentage of Participants Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline

  Month 7 to Month 15

Study Arms (3)

Ranibizumab 0.5 mg monthly - randomized subjects

EXPERIMENTAL

Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.

Drug: Ranibizumab

Ranibizumab 0.5 mg PRN - randomized subjects

EXPERIMENTAL

Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm. No injection was given at the randomization visit. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.

Drug: Ranibizumab

Ranibizumab 0.5 mg monthly - non-randomized subjects

EXPERIMENTAL

Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

Liquid ranibizumab (10 mg/ml) was supplied in a sterile solution in single-use vials.

Also known as: Lucentis

Ranibizumab 0.5 mg PRN - randomized subjects; Ranibizumab 0.5 mg monthly - non-randomized subjects; Ranibizumab 0.5 mg monthly - randomized subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For sexually active women of childbearing potential, use of an appropriate form of contraception (or abstinence) for the duration of the study.
• Foveal center-involved macular edema secondary to branch retinal vein occlusion (BRVO) (including hemi-retinal retinal vein occlusion \[HRVO\]) or central retinal vein occlusion (CRVO).
• Best corrected visual acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) charts of 20/40 to 20/320 (Snellen equivalent) in the study eye.
• Mean central subfield thickness \> 300 µm on 2 spectral-domain optical coherence tomography measurements (screening and Day 0 \[first day of treatment\]).

You may not qualify if:

• History of cerebral vascular accident or myocardial infarction within 3 months prior to Day 0.
• History of any systemic anti-vascular endothelial growth factor (VEGF) or pro-VEGF treatment within 6 months prior to Day 0.
• History of allergy to fluorescein.
• History of allergy to ranibizumab injection or related molecule.
• Uncontrolled blood pressure.
• Pregnancy or lactation.
• Daily use of oral corticosteroids to treat a chronic condition.
• Required treatment with injectable corticosteroids to treat a musculoskeletal condition.
• Participation in an investigational trial within 30 days prior to Day 0 that involved treatment with any drug or device that has not received regulatory approval at the time of study entry.
• Prior episode of retinal vein occlusion (RVO).
• Brisk afferent pupillary defect.
• History of any previous intravitreal anti-VEGF therapy for RVO in the study eye.
• History of previous therapeutic treatment for RVO, other than anti-VEGF therapy, within 4 months prior to the screening visit, including any intraocular corticosteroids.
• History of previous surgical treatment for RVO, including radial optic neurotomy or sheathotomy.
• History or presence of age-related macular degeneration (AMD) (dry form graded as Age-Related Eye Disease Study \[AREDS\] Stage 2 or higher or wet form).

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (42)

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Phoenix, Arizona, 85020, United States

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Tucson, Arizona, 85704, United States

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Beverly Hills, California, 90211, United States

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Chico, California, 95973, United States

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Mountain View, California, 94040, United States

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Oakland, California, 94609, United States

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San Francisco, California, 94107, United States

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Santa Ana, California, 92705, United States

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Santa Barbara, California, 93103, United States

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Torrance, California, 90503, United States

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Colorado Springs, Colorado, 80909, United States

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Golden, Colorado, 80401, United States

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New London, Connecticut, 06320, United States

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Altamonte Springs, Florida, 32701, United States

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Boynton Beach, Florida, 33426, United States

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Lakeland, Florida, 33805, United States

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Augusta, Georgia, 30909, United States

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Chicago, Illinois, 60637, United States

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Baltimore, Maryland, 21287, United States

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Hagerstown, Maryland, 21740, United States

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Boston, Massachusetts, 02114, United States

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Worcester, Massachusetts, 01605, United States

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Jackson, Michigan, 49201, United States

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Edina, Minnesota, 55435, United States

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Las Vegas, Nevada, 89144, United States

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Northfield, New Jersey, 08225, United States

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Teaneck, New Jersey, 07666, United States

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Rochester, New York, 14620, United States

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Charlotte, North Carolina, 28210, United States

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Camp Hill, Pennsylvania, 17011, United States

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Philadelphia, Pennsylvania, 19107, United States

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Pittsburgh, Pennsylvania, 15212, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Ladson, South Carolina, 29456, United States

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West Columbia, South Carolina, 29169, United States

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Rapid City, South Dakota, 57701, United States

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Nashville, Tennessee, 37203, United States

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Abilene, Texas, 79606, United States

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Austin, Texas, 78705, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78240, United States

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The Woodlands, Texas, 77384, United States

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Related Publications (2)

• Yiu G, Huang D, Wang Y, Wang Z, Yang M, Haskova Z. Predictors of As-Needed Ranibizumab Injection Frequency in Patients With Macular Edema Following Retinal Vein Occlusion. Am J Ophthalmol. 2023 May;249:74-81. doi: 10.1016/j.ajo.2023.01.004. Epub 2023 Jan 14.

  PMID: 36646240 DERIVED

• Lloyd Clark W, Liu M, Kitchens J, Wang PW, Haskova Z. Baseline characteristics associated with early visual acuity gains after ranibizumab treatment for retinal vein occlusion. BMC Ophthalmol. 2019 Jan 8;19(1):11. doi: 10.1186/s12886-018-1012-y.

  PMID: 30621653 DERIVED

MeSH Terms

Conditions

Macular Edema

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Communications
• Organization: Genentech, Inc.

800 821-8590

Study Officials

• Gary Sternberg, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2011
• First Posted: January 14, 2011
• Study Start: February 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: April 23, 2014
• Results First Posted: April 23, 2014

Record last verified: 2014-03

Locations

US (42)