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NCT00815360 · ClinicalTrials.gov registry record · Phase 2
Ranibizumab and Peripheral Scatter Laser in Patients With Diabetic Macular Edema and Peripheral Nonperfusion
A Phase 2 study, sponsored by Retina Associates of Florida, P.A..
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT00815360: Completed Phase 2 study, sponsored by Retina Associates of Florida, P.A..
NCT00815360 is a Phase 2 study that has completed, run by Retina Associates of Florida, P.A.. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00815360, a Phase 2 study, has completed, sponsored by Retina Associates of Florida, P.A..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study Summary
To investigate the role of ranibizumab and angiographically-directed peripheral scatter laser therapy in patients with clinically-significant diabetic macular edema (CSME) and peripheral nonperfusion. We propose a novel treatment of CSME in a subgroup of patients defined by a combination of ultrawide-field angiography (UWFA) and optical coherence tomography (OCT). Within this classification scheme, patients with CSME are subdivided by the presence of: 1) focal macular leakage, 2) vitreomacular interface traction, and/or 3) peripheral nonperfusion. The successful treatment of diabetic macular edema would be dictated by pathophysiology-directed therapy based on this classification. The subgroup of interest for this clinical trial is characterized by diabetic macular edema, peripheral nonperfusion on UWFA, and the absence of macular traction on OCT. This group of patients has previously not been well recognized or characterized due to limitations in previous, standard angiographic evaluation of the retinal periphery. We postulate that this subcategory represents one with a high rate of failure of accepted therapies given persistence of the basic pathophysiologic mechanism for CSME, namely ischemia-induced production of Vascular Endothelial Growth Factor (VEGF) from the retinal periphery. This also represents a population of patients with likely recurrence of CSME despite treatment with anti-VEGF therapy alone for the same reason.
Interventions
- DRUG intravitreal injection of ranibizumab
- PROCEDURE peripheral laser
- DRUG intravitreal injection of triamcinolone acetonide
- PROCEDURE macular laser
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2008-02 |
| Est. Completion | 2011-08 |
| Phase | Phase 2 |
What the finished NCT00815360 record still lists
NCT00815360 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 4 interventions - of which intravitreal injection of ranibizumab is the first listed.
NCT00815360 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00815360 about?
NCT00815360 is a clinical study titled "Ranibizumab and Peripheral Scatter Laser in Patients With Diabetic Macular Edema and Peripheral Nonperfusion". To investigate the role of ranibizumab and angiographically-directed peripheral scatter laser therapy in patients with clinically-significant diabetic macular edema (CSME) and peripheral nonperfusion. We propose a novel treatment of CSME in a subgroup of patients defined by a combination of ultrawid...
What is the current status of trial NCT00815360?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2008-02. Estimated completion is 2011-08.
What interventions are being tested in trial NCT00815360?
The interventions under investigation include: intravitreal injection of ranibizumab (DRUG), peripheral laser (PROCEDURE), intravitreal injection of triamcinolone acetonide (DRUG), macular laser (PROCEDURE).
Who is sponsoring clinical trial NCT00815360?
This trial is sponsored by Retina Associates of Florida, P.A., which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00815360's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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