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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: Completed Phase 4 study, sponsored by Oklahoma State University Center for Health Sciences.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Visual acuity is often measured using a chart called the ETDRS chart (Early Treatment Diabetic Retinopathy Study). A letter score is calculated based on the number of letters that can be correctly identified from specified distances. Higher letter scores correspond to better visual acuity. Lower letter scores mean poorer visual acuity. In this study the baseline visual acuity in letters is subtracted from the visual acuity in letters measured at the 12 month visit providing a letter score of vis
Interventions
- DRUG Verteporfin
- DRUG Ranibizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2007-05 |
| Est. Completion | 2010-04 |
| Phase | Phase 4 |
What the finished NCT00473642 record still lists
NCT00473642 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Verteporfin is the first listed.
NCT00473642 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT00473642's enrollment target sits among peer trials
31 1544th of 2000 higher than 449 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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