Photodynamic and Pharmacologic Treatment of CNV (PBS)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Mid-Atlantic Retina Consultations, Inc.

ClinicalTrials.gov Identifier:

NCT00570193

First received: December 6, 2007

Last updated: July 6, 2012

Last verified: July 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Choroidal Neovascularization Macular Degeneration	Drug: verteporfin (Visudyne) Drug: ranibizumab (Lucentis)	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Photodynamic and Pharmacologic Treatment of Choroidal Neovascularization (Photodynamic Booster Study)

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Verteporfin Ranibizumab

U.S. FDA Resources

Further study details as provided by Mid-Atlantic Retina Consultations, Inc.:

Primary Outcome Measures:

Visual change [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Frequency of treatment [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment:	41
Study Start Date:	December 2006
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: I Combined treatment with verteporfin (Visudyne) and ranibizumab (Lucentis)	Drug: 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 Other Names: Visudyne = verteporfin Lucentis = ranibizumab
Experimental: II Treatment with ranibizumab (Lucentis)	Drug: ranibizumab (Lucentis) ranibizumab (Lucentis) 0.3 mg on weeks 1,5,9,13,17,21,25,29,33&37 per study protocol Other Name: Lucentis = ranibizumab

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All previously untreated CNV secondary to MD

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00570193

Sponsors and Collaborators

Mid-Atlantic Retina Consultations, Inc.

Investigators

Principal Investigator:

Nabil M Jabbour, MD

Mid-Atlantic Retina Consultations

More Information

No publications provided

Responsible Party:	Mid-Atlantic Retina Consultations, Inc.
ClinicalTrials.gov Identifier:	NCT00570193 History of Changes
Other Study ID Numbers:	PBS-100-388
Study First Received:	December 6, 2007
Last Updated:	July 6, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases

Uveal Diseases
Verteporfin
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013

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