Dorzolamide-timolol Drops With Injections to Treat AMD,RVO or DME.
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|ClinicalTrials.gov Identifier: NCT02571972|
Recruitment Status : Completed
First Posted : October 8, 2015
Last Update Posted : April 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Wet Macular Degeneration Age-related Macular Degeneration Diabetic Macular Edema Retinal Vein Occlusion||Drug: Dorzolamide-timolol||Phase 2|
Intravitreal anti-vascular endothelial growth factor (VEGF) agents, including bevacizumab, ranibizumab, and aflibercept, have become the gold standard treatment for neovascular age-related macular degeneration (AMD). Various treatment modalities using these agents have been proposed, including monthly, pro re nata, and treat-and-extend philosophies. Despite frequent and consistent treatment with anti-VEGF therapy, there is a subset of patients who are incomplete or non-responders and have persistent evidence of exudation on spectral-domain optical coherence tomography (SD-OCT), including subretinal fluid (SRF) and/or intraretinal edema.
While clearance of intravitreal anti-VEGF drugs is not completely understood, some studies have suggested that outflow through the anterior chamber may contribute. We hypothesized that by decreasing aqueous production, outflow may also be reduced which could delay the clearance of intravitreal drugs. As a result, we chose topical dorzolamide-timolol since it is a potent aqueous suppressant and is readily available due to its common use in the treatment of glaucoma. The current study aimed to evaluate the efficacy of topical dorzolamide-timolol on anatomic and visual outcomes in anti-VEGF non-responders with neovascular AMD.
Significance: The results of this study will help delineate whether topical aqueous suppression may be useful as adjuvant therapy in patients receiving chronic intravitreal anti-VEGF injections.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Topical Aqueous Suppressant on Anatomic and Functional Response to Intravitreal Anti-vascular Endothelial Growth Factor Injections in Age-related Macular Degeneration, Retinal Vein Occlusions or Diabetic Macular Edema.|
|Actual Study Start Date :||October 1, 2014|
|Actual Primary Completion Date :||July 10, 2017|
|Actual Study Completion Date :||December 1, 2017|
On enrollment, eligible patients will be started on topical dorzolamide-timolol in the study eye twice daily for the study duration
Other Name: Cosopt
- Mean central macular thickness (CMT) [ Time Frame: 3 visits (8-12 weeks) ]Mean central retinal thickness (CMT) on SD-OCT on 1 visit prior to enrollment and all visits subsequent to study enrollment
- Visual acuity [ Time Frame: 3 visits (8-12 weeks) ]Visual acuity
- Maximum subretinal fluid height [ Time Frame: 3 visits (8-12 weeks) ]Measurement based on SD-OCT
- Maximum pigment epithelial detachment height [ Time Frame: 3 visits (8-12 weeks) ]Measurement based on SD-OCT
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02571972
|United States, Pennsylvania|
|Wills Eye Hospital / Mid Atlantic Retina|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Jason Hsu, MD||Wills Eye Hospital, Mid Atlantic Retina|