Dorzolamide-timolol Drops With Injections to Treat AMD, RVO or DME.

Diabetic Macular Edema Clinical Trial

Official title:

Effect of Topical Aqueous Suppressants on Response to Intravitreal Anti-vascular Endothelial Growth Factor Injections in Age-related Macular Degeneration (AMD), Retinal Vein Occlusions (RVO) or Diabetic Macular Edema (DME).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02571972
• Other study ID #: IRB#14-435
• Status: Completed
• Phase: Phase 2
• Start date: February 1, 2015
• Est. completion date: December 20, 2015

Study information

• Verified date: December 2019
• Source: Wills Eye
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 20, 2015
• Est. primary completion date: September 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient of Wills Eye Hospital Retina Service and/or Mid Atlantic Retina.

2. Volunteer patients age 18 years and older.

3. Healthy enough to participate in the study.

4. Willing and able to consent to participation in the study.

5. Diagnosis of wet age-related macular degeneration

6. Prior treatment with at least 4 injections of anti-VEGF agents in the past 6 months and persistent intraretinal and/or subretinal fluid on SD-OCT at each visit during this period

7. Injection of the same anti-VEGF agent for at least two visits prior to study enrollment

8. Fixed interval between at least two visits prior to study enrollment

Exclusion Criteria:

1. History of uveitis

2. Any ophthalmic surgery within previous 6 months, including cataract extraction.

3. Any history of vitrectomy

4. History of any glaucoma drop usage or prior glaucoma surgery

5. Systemic diuretic or corticosteroid usage

6. Any contraindication (bradycardia, decompensated heart failure, or reactive

7. airway disease) for topical use of a beta-blocker

8. Any history of sulfonamide allergy

-

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Diabetic Macular Edema
• Edema
• Macular Degeneration
• Macular Edema
• Retinal Vein Occlusion
• Wet Macular Degeneration

Intervention

Drug:
• Dorzolamide-timolol
On enrollment, eligible patients will be started on topical dorzolamide-timolol in the study eye twice daily for the study duration

Locations

Country	Name	City	State
United States	Wills Eye Hospital / Mid Atlantic Retina	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Wills Eye	J. Arch McNamara Research Fund, Mid Atlantic Retina

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	3 visits (8-12 weeks)
Secondary	Visual Acuity	LogMAR Visual acuity on enrollment and final visit	3 visits (8-12 weeks)
Secondary	Maximum Subretinal Fluid Height	Measurement based on SD-OCT	3 visits (8-12 weeks)
Secondary	Maximum Pigment Epithelial Detachment Height	Measurement based on SD-OCT	3 visits (8-12 weeks)