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Photodynamic and Pharmacologic Treatment of CNV

NCT ID: NCT00570193

Last Updated: 2012-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2011-06-30

Brief Summary

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The goal of this pilot study is to validate the use of the combination of Lucentis (ranibizumab) and Visudyne (verteporfin) in the treatment of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) and to explore the use of a volumetric analysis of the CNV lesion to determine disease activity, response to therapy, and as a tool for determining the need for retreatment.

Detailed Description

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Conditions

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Choroidal Neovascularization Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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I

Combined treatment with verteporfin (Visudyne) and ranibizumab (Lucentis)

Group Type EXPERIMENTAL

verteporfin (Visudyne)

Intervention Type DRUG

Verteporfin (Visudyne) 6 mg/m2 at 300mW/cm2 given on week O and then at week 5, given as indicated per protocol; ranibizumab (Lucentis) 0.3 mg given at week 1

II

Treatment with ranibizumab (Lucentis)

Group Type EXPERIMENTAL

ranibizumab (Lucentis)

Intervention Type DRUG

ranibizumab (Lucentis) 0.3 mg on weeks 1,5,9,13,17,21,25,29,33\&37 per study protocol

Interventions

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verteporfin (Visudyne)

Verteporfin (Visudyne) 6 mg/m2 at 300mW/cm2 given on week O and then at week 5, given as indicated per protocol; ranibizumab (Lucentis) 0.3 mg given at week 1

Intervention Type DRUG

ranibizumab (Lucentis)

ranibizumab (Lucentis) 0.3 mg on weeks 1,5,9,13,17,21,25,29,33\&37 per study protocol

Intervention Type DRUG

Other Intervention Names

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Visudyne = verteporfin Lucentis = ranibizumab Lucentis = ranibizumab

Eligibility Criteria

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Inclusion Criteria

* All previously untreated CNV secondary to MD
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mid-Atlantic Retina Consultations, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nabil M Jabbour, MD

Role: PRINCIPAL_INVESTIGATOR

Mid-Atlantic Retina Consultations

Other Identifiers

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PBS-100-388

Identifier Type: -

Identifier Source: org_study_id