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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 is a Phase 2 study that has completed, run by Retina Associates of Florida, P.A.. The registered enrollment target is 22 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00815360
The ClinicalTrials.gov registry entry for NCT00815360 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Retina Associates of Florida, P.A., which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which intravitreal injection of ranibizumab is the first listed.
NCT00815360 reports 0 study locations.
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.
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