Abstract | PURPOSE: DESIGN: Randomized, sham-injection controlled, double-masked, multicenter, phase II trial. PARTICIPANTS: METHODS: Study treatment was administered in the mid-vitreous cavity by injection. Post-treatment safety and efficacy assessments were made at baseline and on days 7, 14, and 28 and months 3, 6, and 12 after injection. Secondary efficacy end points were exploratory in nature. MAIN OUTCOME MEASURES: RESULTS: The safety of ocriplasmin in patients with VMA and wet AMD was shown to be comparable to the known safety profile, with the majority of adverse events in the study eye occurring in the first 7 days after study treatment. A greater proportion of patients achieved VMA resolution and total PVD at month 12 with ocriplasmin compared with sham treatment. There was a decrease in the number of anti- VEGF injections with ocriplasmin at month 12 compared with the sham group, although no differences in visual acuity were observed. CONCLUSIONS:
Ocriplasmin treatment in this population seems to be generally safe and well tolerated and resulted in more patients achieving VMA resolution and PVD with less anti- VEGF use compared with sham treatment.
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Authors | Roger L Novack, Giovanni Staurenghi, Aniz Girach, Nirodhini Narendran, Michael Tolentino |
Journal | Ophthalmology
(Ophthalmology)
Vol. 122
Issue 4
Pg. 796-802
(Apr 2015)
ISSN: 1549-4713 [Electronic] United States |
PMID | 25435217
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2015 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Fibrinolytic Agents
- Peptide Fragments
- microplasmin
- Fibrinolysin
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Topics |
- Aged
- Aged, 80 and over
- Double-Blind Method
- Exudates and Transudates
- Female
- Fibrinolysin
(adverse effects, therapeutic use)
- Fibrinolytic Agents
(adverse effects, therapeutic use)
- Humans
- Intravitreal Injections
- Male
- Middle Aged
- Peptide Fragments
(adverse effects, therapeutic use)
- Retinal Diseases
(drug therapy, physiopathology)
- Tissue Adhesions
(drug therapy)
- Visual Acuity
(physiology)
- Vitreous Body
(drug effects)
- Vitreous Detachment
(drug therapy, physiopathology)
- Wet Macular Degeneration
(drug therapy, physiopathology)
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