Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial

NCT00363168 | Completed Phase 1 Results

• 1 other identifier: NA_00001650
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This research is being done to look at the effects of an experimental drug, ranibizumab, on a condition called "predominantly hemorrhagic subfoveal choroidal neovascularization (CNV)" due to wet age-related macular degeneration. A predominantly hemorrhagic CNV lesion is diagnosed when at least 50% of the choroidal neovascular lesion is occupied by blood under the retina. We want to find out if injections of ranibizumab into the eye will help patients with this condition.

Conditions

Choroidal Neovascularization

Keywords

Hemorrhagic Choroidal Neovascularization

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Avoiding 15 or More Letter Loss of Best Corrected Visual Acuity From Baseline to 12 Months on an Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Chart Measured at 4 Meters.

  Visual acuity measured prior to first treatment with ranibizumab and at 12 months following the first treatment were compared for each subject enrolled in the study. The 12 month follow-up visual acuity was subtracted from the baseline visual acuity. Avoiding a 15 or more letter loss in visual acuity was considered a successful outcome.

  12 months

Secondary Outcomes (4)

• Retinal Changes on Funduscopy

  12 months

• Retinal Thickness Measured by Optical Coherence Tomography (OCT)

  12 months

• Fluorescein Leakage on Fluorescein Angiography

  12 months

• Number of Subjects Experiencing Complications Related to Drug or Its Administration

  12 months after last injection

Study Arms (2)

A

EXPERIMENTAL

0.3 mg/0.05 ml dose of ranibizumab

Drug: Ranibizumab

B

EXPERIMENTAL

0.5 mg/0.05 ml dose of ranibizumab

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

0.3 mg/0.05 ml dose

Also known as: Lucentis

A

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be eligible if the following criteria are met:
• Ability to provide written informed consent and comply with study assessments for the full duration of the study.
• Predominantly hemorrhagic subfoveal CNV (at least 50% of the lesion composed of hemorrhage) from age-related macular degeneration (AMD) resulting in visual acuity of 20/40 or worse.
• Age greater than 50 years.
• Participant must have media clear enough to permit fundus photography, fluorescein angiography, and optical coherence tomography.

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from this study:
• Known hypersensitivity to humanized monoclonal antibodies
• History (within past 6 months) or evidence of severe cardiac disease (apparent in electrocardiogram abnormalities, clinical history of unstable angina, acute coronary syndrome, myocardial infarction, revascularization procedure within 6 months prior to baseline, atrial or ventricular tachyarrhythmias requiring ongoing treatment).
• History of stroke within 6 months of study entry.
• Current acute ocular or periocular infection.
• Any major surgical procedure within one month of study entry.
• Known serious allergies to fluorescein dye.
• Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, Protein Kinase C inhibitors, etc) within last 6 months.
• Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye within the last 6 months.
• History of subfoveal laser treatment in the study eye.
• History of other visually-limiting conditions such as optic neuropathy, amblyopia, choroidal neovascularization due to causes other than AMD in the study eye.
• Ocular inflammation (including trace or above) in the study eye.
• Inability to comply with study or follow up procedures.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Genentech, Inc.: collaborator

Study Sites (1)

The Wilmer Eye Institute at Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• Chang MA, Do DV, Bressler SB, Cassard SD, Gower EW, Bressler NM. Prospective one-year study of ranibizumab for predominantly hemorrhagic choroidal neovascular lesions in age-related macular degeneration. Retina. 2010 Sep;30(8):1171-6. doi: 10.1097/IAE.0b013e3181dd6d8a.

  PMID: 20827138 RESULT

MeSH Terms

Conditions

Choroidal Neovascularization

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: Neil M. Bressler
• Organization: Johns Hopkins University

nbressler@jhmi.edu

410-955-8342

Study Officials

• Neil M. Bressler, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 9, 2006
• First Posted: August 15, 2006
• Study Start: August 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: May 1, 2009
• Last Updated: October 19, 2012
• Results First Posted: October 19, 2012

Record last verified: 2012-09

Locations

US (1)