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Photodynamic and Pharmacologic Treatment of CNV

Photodynamic and Pharmacologic Treatment of Choroidal Neovascularization (Photodynamic Booster Study)

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00570193
Acronym
PBS
Enrollment
41
Registered
2007-12-10
Start date
2006-12-31
Completion date
2011-06-30
Last updated
2012-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Choroidal Neovascularization, Macular Degeneration

Brief summary

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.

Interventions

DRUGverteporfin (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

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

Sponsors

Mid-Atlantic Retina Consultations, Inc.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* All previously untreated CNV secondary to MD

Design outcomes

Primary

MeasureTime frame
Visual change18 months

Secondary

MeasureTime frame
Frequency of treatment18 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026