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

NCT ID: NCT00681889

Last Updated: 2012-11-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-09-30

Brief Summary

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

Detailed Description

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This is an open label, single site, uncontrolled, single group assignment, safety/efficacy, Phase I study of topical administered ranibizumab in subjects with corneal neovascularization. Ten eyes of patients with corneal neovascularization will be recruited. Patients with superficial or deep corneal neovascularization that extends farther than 2 mm from the limbus will be considered.

Conditions

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Corneal Neovascularization

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Arm

10 Patients will receive treatment (Ranibizumab)

Group Type EXPERIMENTAL

Ranibizumab

Intervention Type DRUG

10 Patients will receive treatment (Ranibizumab)

Interventions

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Ranibizumab

10 Patients will receive treatment (Ranibizumab)

Intervention Type DRUG

Other Intervention Names

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Lucentis

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Premenopausal women not using adequate contraception (The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch)
* Participation in another simultaneous medical investigation or trial.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Reza Dana, MD

OTHER

Sponsor Role lead

Responsible Party

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Reza Dana, MD

Professor of Ophthalmology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Reza Dana, M.D., MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts Eye and Ear Infirmary

Locations

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Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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07-11-069

Identifier Type: OTHER

Identifier Source: secondary_id

07-11-069

Identifier Type: -

Identifier Source: org_study_id