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

NCT02571972 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IRB#14-435
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

dorzolamide-timolol; topical aqueous suppression; neovascular age-related macular degeneration; macular edema; intravitreal injection; anti-vascular endothelial growth factor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Visual Acuity

  3 visits (8-12 weeks)

• Maximum Subretinal Fluid Height

  3 visits (8-12 weeks)

• Maximum Pigment Epithelial Detachment Height

  3 visits (8-12 weeks)

Study Arms (1)

Dorzolamide-timolol

EXPERIMENTAL

* On enrollment, eligible patients will have visual acuity testing, intraocular pressure, dilated fundoscopic examination, SD-OCT scan and will then receive the same intravitreal pharmacologic agent administered at prior visit. * Subsequent follow-up visits will be at an identical interval to pre-enrollment visit intervals (4, 5, or 6 week intervals) for the study duration. * Each subsequent visit will consist of visual acuity testing, intraocular pressure, dilated fundoscopic examination, SD-OCT scan, and intravitreal injection of same pharmacologic agent as prior visits * At study conclusion, mean central macular thickness, maximum subretinal fluid height, and maximum pigment epithelial detachment height will be measured over the study period for all patients

Drug: Dorzolamide-timolol

Interventions

Dorzolamide-timolol DRUG

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

Also known as: Cosopt

Dorzolamide-timolol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient of Wills Eye Hospital Retina Service and/or Mid Atlantic Retina.
• Volunteer patients age 18 years and older.
• Healthy enough to participate in the study.
• Willing and able to consent to participation in the study.
• Diagnosis of wet age-related macular degeneration
• 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
• Injection of the same anti-VEGF agent for at least two visits prior to study enrollment
• Fixed interval between at least two visits prior to study enrollment

You may not qualify if:

• 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

Sponsors & Collaborators

• Wills Eye: lead
• J. Arch McNamara Research Fund: collaborator
• Mid Atlantic Retina: collaborator

Study Sites (1)

Wills Eye Hospital / Mid Atlantic Retina

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (3)

• 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.

  PMID: 18682969 BACKGROUND

• 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.

  PMID: 26914218 RESULT

• 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.

  PMID: 29864044 DERIVED

MeSH Terms

Conditions

Wet Macular Degeneration; Macular Degeneration; Retinal Vein Occlusion; Macular Edema

Interventions

dorzolamide-timolol combination

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Jason Hsu
• Organization: Retina Service of Wills Eye Hospital, Mid Atlantic Retina

jhsu@midatlanticretina.com

215-928-3092

Study Officials

• Jason Hsu, MD

  Wills Eye Hospital, Mid Atlantic Retina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 8, 2015
• Study Start: February 1, 2015
• Primary Completion: September 30, 2015
• Study Completion: December 20, 2015
• Last Updated: December 3, 2019
• Results First Posted: December 3, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)