NCT00157976

Brief Summary

The purpose of this study is to confirm the efficacy and safety of rostaporfin (PHOTREX) photodynamic therapy (PDT) in the treatment of classic and occult subfoveal choroidal neovascularization (CNV) associated with age-related macular degeneration (AMD).

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
660

participants targeted

Target at P75+ for phase_3

Geographic Reach
4 countries

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

December 1, 2005

Status Verified

November 1, 2005

First QC Date

September 8, 2005

Last Update Submit

November 29, 2005

Conditions

Macular Degeneration

Keywords

Macular DegenerationAMDVisual Acuity

Outcome Measures

Primary Outcomes (1)

  • Visual Acuity

Secondary Outcomes (1)

  • Angiographic changes

Interventions

Photrex (rostaporfin)DRUG

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with age greater than or equal to 50 years with at least one subfoveal CNV membrane secondary to AMD that can be demonstrated by fluorescein angiography.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Multiple Investigators

Sofia, Bulgaria

RECRUITING

Multiple Investigators

Brno-Bohunice, Olomouc, Praha, Czechia

RECRUITING

Multiple Investigators

Warsaw, Bydgoszcz, Lubin, Poland

RECRUITING

Multiple Investigators

Bucharest, Romania

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Interventions

tin etiopurpurin

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Wendy J. Snyder, PhD

    Miravant Pharmaceuticals

    STUDY DIRECTOR

Central Study Contacts

Miravant Pharmaceuticals

CONTACT

1-800-685-2959ctinfo@miravant.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

September 1, 2005

Last Updated

December 1, 2005

Record last verified: 2005-11

Locations

BU(1)PL(1)RO(1)CZ(1)