Study To Determine Safety/Efficacy of Lucentis For Treatment Of Retinal Angiomatous Proliferation Secondary To Age Related Macular Degeneration

NCT ID: NCT00395707

Last Updated: 2009-02-09

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2008-04-30

Brief Summary

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The primary objective of this study is to determine the safety \& efficacy of ranibizumab for the treatment of retinal angiomatous proliferation secondary to age related macular degeneration.

Detailed Description

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This study will be a phase I/II open label interventional case series. Twenty patients with retinal angiomatous proliferation will be randomized to receive intravitreal ranibizumab at a dose of 0.3mg/0.05 ml or 0.5mg/0.05 ml. Patients will receive ranibizumab via a pars plana injection on a monthly basis for a total duration of therapy of 12 months. Patients will be followed for a complete 12-month treatment course.

Conditions

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Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Lucentis 0.3mg/0.05 ml

Group Type ACTIVE_COMPARATOR

Lucentis

Intervention Type DRUG

0.3mg/0.05 ml or 0.5mg/0.05 ml

Ranibizumab

Intervention Type DRUG

0.3mg/0.05 ml or 0.5mg/0.05 ml

Ranibizumab (Lucentis)

Intervention Type DRUG

0.3mg/0.05 ml intravitreally

2

Lucentis 0.5mg/0.05 ml

Group Type ACTIVE_COMPARATOR

Lucentis

Intervention Type DRUG

0.3mg/0.05 ml or 0.5mg/0.05 ml

Ranibizumab

Intervention Type DRUG

0.3mg/0.05 ml or 0.5mg/0.05 ml

Ranibizumab (Lucentis)

Intervention Type DRUG

0.5mg/0.05 ml

Interventions

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Lucentis

0.3mg/0.05 ml or 0.5mg/0.05 ml

Intervention Type DRUG

Ranibizumab

0.3mg/0.05 ml or 0.5mg/0.05 ml

Intervention Type DRUG

Ranibizumab (Lucentis)

0.3mg/0.05 ml intravitreally

Intervention Type DRUG

Ranibizumab (Lucentis)

0.5mg/0.05 ml

Intervention Type DRUG

Other Intervention Names

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Ranibizumab Lucentis Ranibizumab Lucentis Ranibizumab 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 \> 50 years
* Definite characteristic signs of age related macular degeneration including drusen
* Presence of retinal angiomatous proliferation as determined by clinical signs (intra retinal hemorrhage, retinal edema, cystic retinal edema) and angiography (occult leakage on fluorescein angiography, hot spot on static ICG, visible RAP lesion of high speed ICG)

Exclusion Criteria

* Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy in the study eye (predominantly classic CNV can however only be included if the subject had up to 3 prior PDT treatments)
* Treatment with verteporfin in the non-study eye less than 7 days preceding Day 0
* Previous participation in a clinical trial (for either eye) involving anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)
* Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
* Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0
* History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye
* Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals)
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

The National Retina Institute

OTHER

Sponsor Role lead

Responsible Party

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National Retina Institute

Principal Investigators

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Thomas M Johnson, MD

Role: PRINCIPAL_INVESTIGATOR

National Retina Institute

Locations

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National Retina Institute

Chevy Chase, Maryland, United States

Site Status

National Retina Institute

Towson, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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FVF3423s

Identifier Type: -

Identifier Source: org_study_id

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