Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00473642 · ClinicalTrials.gov registry record · Phase 4
Reduced Fluence Photodynamic Therapy (PDT) With Visudyne in Combination With Lucentis for Age-Related Macular Degeneration
A Phase 4 study, sponsored by Oklahoma State University Center for Health Sciences.
- Completed
- Registry status
- Phase 4
- Development phase
- 31
- Enrollment target
NCT00473642 is a Phase 4 study that has completed, run by Oklahoma State University Center for Health Sciences. The registered enrollment target is 31 participants.
The verdict
NCT00473642, a Phase 4 study, has completed, sponsored by Oklahoma State University Center for Health Sciences.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 31 participants
- Enrollment target
Study Summary
In this pilot study the researchers will evaluate the safety and efficacy of 50% reduced fluence PDT combination therapy with ranibizumab. The researchers hope to gain information regarding the use of reduced fluence PDT combination therapy. The information gained from this pilot study may prompt further definitive studies comparing the safety and efficacy of both standard fluence PDT combination therapy, reduced fluence PDT combination therapy, and ranibizumab monotherapy. The study will compare the use of combination therapy with ranibizumab and verteporfin PDT to ranibizumab alone in patients with exudative age-related macular degeneration (AMD). All patients will receive three consecutive monthly treatments with ranibizumab. Patients will be randomized 1:1:1 to 3 groups. Patients randomized to group 1 will receive only ranibizumab. Patients randomized to group 2 will also receive one treatment with reduced fluence (50% fluence) verteporfin PDT at day 0. Patients randomized to group 3 will also receive one treatment with standard fluence verteporfin PDT. All patients will also be evaluated for possible retreatment with ranibizumab and verteporfin PDT according to established criteria. Thirty patients will be recruited from one U.S. sites. Randomization will occur at the time of entry into the study. Follow-up will continue until month 12 (from day 0) in all subjects.
Interventions
- DRUG Verteporfin
- DRUG Ranibizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2007-05 |
| Est. Completion | 2010-04 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00473642
The ClinicalTrials.gov registry entry for NCT00473642 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oklahoma State University Center for Health Sciences, which has 24 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Verteporfin is the first listed.
NCT00473642 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00473642 about?
NCT00473642 is a clinical study titled "Reduced Fluence Photodynamic Therapy (PDT) With Visudyne in Combination With Lucentis for Age-Related Macular Degeneration". In this pilot study the researchers will evaluate the safety and efficacy of 50% reduced fluence PDT combination therapy with ranibizumab. The researchers hope to gain information regarding the use of reduced fluence PDT combination therapy. The information gained from this pilot study may prompt fu...
What is the current status of trial NCT00473642?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 31 participants. The study started on 2007-05. Estimated completion is 2010-04.
What interventions are being tested in trial NCT00473642?
The interventions under investigation include: Verteporfin (DRUG), Ranibizumab (DRUG).
Who is sponsoring clinical trial NCT00473642?
This trial is sponsored by Oklahoma State University Center for Health Sciences, which has 24 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.