Effectiveness and Safety of Topical Ranibizumab for Treatment of Corneal Neovascularization (NV)

NCT00681889 | Completed Phase 1 Results

• 1 other identifier: 07-11-069
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effectiveness and safety of ranibizumab (Lucentis) in treatment of corneal neovascularization.

Conditions

Corneal Neovascularization

Outcome Measures

Primary Outcomes (2)

• Incidence and Severity of Ocular Adverse Event

  Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing

  16 Weeks

• Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs

  16 Weeks

Secondary Outcomes (2)

• Efficacy by Comparison Size and Extent of Blood Vessels in Baseline and Follow-up Corneal Photographs

  Prospective

• Efficacy by Measuring Mean Change of BCVA

  Prospective

Study Arms (1)

Treatment Arm

EXPERIMENTAL

10 Patients will receive treatment (Ranibizumab)

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

10 Patients will receive treatment (Ranibizumab)

Also known as: Lucentis

Treatment Arm

Eligibility Criteria

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

You may qualify if:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study
• Age \> 18 years old
• Patients with superficial or deep corneal neovascularization that extends farther than 2 mm from the limbus

You may not qualify if:

• Has received investigational therapy within 60 days prior to study entry
• Has received treatment with anti-VEGF agents (intraocular or systemic) within 45 days of study entry
• Concurrent use of systemic anti-VEGF agents
• Full thickness or lamellar keratoplasty within 90 days prior to study entry
• Ocular surface reconstruction within 90 days prior to study entry
• Other ocular surgeries within 90 days prior to study entry
• Corneal or ocular surface infection within 90 days prior to study entry
• Ocular or periocular malignancy
• Contact lens (excluding bandage contact lens) within 30 days prior to study entry
• Persistent epithelial defect (\>1mm2 and ≥14 days duration) within 30 days prior to study entry
• Systemic, intravitreal, or periocular steroids within 30 days prior to study entry
• Change in dose/frequency of topical steroids and/or NSAIDs within 30 days prior to study entry
• Hypertension: systolic BP \> 150 or diastolic BP \> 90
• History of thromboembolic event within 6 months prior to study entry
• Current diagnosis of diabetes, Pregnancy (positive pregnancy test) or lactation

Sponsors & Collaborators

• Reza Dana, MD: lead

Study Sites (1)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Corneal Neovascularization

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Corneal 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

Limitations and Caveats

Further and larger studies are needed to better establish the efficacy profile of this drug and optimize its dosing and formulation.

Results Point of Contact

• Title: Dr. Reza Dana
• Organization: Massachusetts Eye and Ear Infirmary

Cornea_Research@meei.harvard.edu

617-573-3313

Study Officials

• Reza Dana, M.D., MPH

  Massachusetts Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Ophthalmology

Study Record Dates

• First Submitted: May 19, 2008
• First Posted: May 21, 2008
• Study Start: April 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2010
• Last Updated: November 8, 2012
• Results First Posted: November 8, 2012

Record last verified: 2012-10

Locations

US (1)