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| Name | Class |
|---|---|
| J. Arch McNamara Research Fund | OTHER |
| Mid Atlantic Retina | OTHER |
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This study seeks to evaluate the effect of topical aqueous suppression on the anatomic and functional response to intravitreal anti-vascular endothelial growth factor (VEGF) injections in non-responders with wet age-related macular degeneration.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dorzolamide-timolol | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dorzolamide-timolol | Drug | On enrollment, eligible patients will be started on topical dorzolamide-timolol in the study eye twice daily for the study duration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Central Subfield Thickness (CST) | Mean central subfield thickness (CST) on spectral domain optical coherence tomography (SD-OCT) on 1 visit prior to enrollment and all visits subsequent to study enrollment | 3 visits (8-12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | LogMAR Visual acuity on enrollment and final visit | 3 visits (8-12 weeks) |
| Maximum Subretinal Fluid Height | Measurement based on SD-OCT |
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Inclusion Criteria:
Exclusion Criteria:
History of uveitis
Any ophthalmic surgery within previous 6 months, including cataract extraction.
Any history of vitrectomy
History of any glaucoma drop usage or prior glaucoma surgery
Systemic diuretic or corticosteroid usage
Any contraindication (bradycardia, decompensated heart failure, or reactive
airway disease) for topical use of a beta-blocker
Any history of sulfonamide allergy
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| Name | Affiliation | Role |
|---|---|---|
| Jason Hsu, MD | Wills Eye Hospital, Mid Atlantic Retina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wills Eye Hospital / Mid Atlantic Retina | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18682969 | Background | Byeon SH, Kwon OW, Song JH, Kim SE, Park YS. Prolongation of activity of single intravitreal bevacizumab by adjuvant topical aqueous depressant (Timolol-Dorzolamide). Graefes Arch Clin Exp Ophthalmol. 2009 Jan;247(1):35-42. doi: 10.1007/s00417-008-0917-1. Epub 2008 Aug 6. | |
| 26914218 | Result | Sridhar J, Hsu J, Shahlaee A, Garg SJ, Spirn MJ, Fineman MS, Vander J. Topical Dorzolamide-Timolol With Intravitreous Anti-Vascular Endothelial Growth Factor for Neovascular Age-Related Macular Degeneration. JAMA Ophthalmol. 2016 Apr;134(4):437-43. doi: 10.1001/jamaophthalmol.2016.0045. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dorzolamide-timolol | On enrollment, eligible patients will be started on topical dorzolamide 2%-timolol 0.5% 1 drop in the study eye twice daily for the study duration |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dorzolamide-timolol |
Dorzolamide-timolol: On enrollment, eligible patients will be started on topical dorzolamide-timolol in the study eye twice daily for the study duration |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Central Subfield Thickness (CST) | Mean central subfield thickness (CST) on spectral domain optical coherence tomography (SD-OCT) on 1 visit prior to enrollment and all visits subsequent to study enrollment | Only 8 of 10 eyes completed study visit 3. The protocol only required follow-up through study visit 2. | Posted | Mean | Standard Deviation | microns | 3 visits (8-12 weeks) |
|
8 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dorzolamide-timolol |
Dorzolamide-timolol: On enrollment, eligible patients will be started on topical dorzolamide-timolol in the study eye twice daily for the study duration |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jason Hsu | Retina Service of Wills Eye Hospital, Mid Atlantic Retina | 215-928-3092 | jhsu@midatlanticretina.com |
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| ID | Term |
|---|---|
| D057135 | Wet Macular Degeneration |
| D008268 | Macular Degeneration |
| D012170 | Retinal Vein Occlusion |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
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| ID | Term |
|---|---|
| C479140 | dorzolamide-timolol combination |
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|
| 3 visits (8-12 weeks) |
| Maximum Pigment Epithelial Detachment Height | Measurement based on SD-OCT | 3 visits (8-12 weeks) |
| 29864044 | Derived | Obeid A, Hsu J, Ehmann D, Gao X, Sridhar J, Chiang A, Park CH, Ho AC. TOPICAL DORZOLAMIDE-TIMOLOL WITH INTRAVITREOUS ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR FOR RETINAL VEIN OCCLUSION: A PILOT STUDY. Retin Cases Brief Rep. 2021 Mar 1;15(2):120-126. doi: 10.1097/ICB.0000000000000752. |
| Eyes |
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| years |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
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| Intravitreous anti-vascular endothelial growth factor (VEGF) agent | Intravitreous anti-vascular endothelial growth factor drug that eye was receiving at time of enrollment. | Count of Units | Eyes | Eyes |
|
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| Prior injections with same anti-VEGF drug | Number of injections with the same anti-VEGF drug prior to enrollment | Mean | Full Range | Injections | Eyes |
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| Pseudophakic | Number of eyes that had prior cataract surgery with an intraocular lens implant | Count of Units | Eyes | Eyes |
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| Current treatment interval | Interval between intravitreal anti-VEGF injections prior to study enrollment. Same interval was maintained for study duration. | Count of Units | Eyes | Eyes |
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| Secondary | Visual Acuity | LogMAR Visual acuity on enrollment and final visit | Posted | Mean | Standard Deviation | logMAR | 3 visits (8-12 weeks) | Eyes | Eyes |
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| Secondary | Maximum Subretinal Fluid Height | Measurement based on SD-OCT | Only 8 of 10 eyes completed study visit 3. The protocol only required follow-up through study visit 2. | Posted | Mean | Standard Deviation | microns | 3 visits (8-12 weeks) | Eyes | Eyes |
|
|
|
| Secondary | Maximum Pigment Epithelial Detachment Height | Measurement based on SD-OCT | Only 8 of 10 eyes completed study visit 3. The protocol only required follow-up through study visit 2. | Posted | Mean | Standard Deviation | microns | 3 visits (8-12 weeks) | Eyes | Eyes |
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| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 12 |
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| D013927 |
| Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Enrollment visit |
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| Study visit 1 |
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| Study visit 2 |
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| Study visit 3 |
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| Final visit |
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| Enrollment visit |
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| Study visit 1 |
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| Study visit 2 |
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| Study visit 3 |
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| Final visit |
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