NCT03034772

Brief Summary

A previous pilot study demonstrated that commonly available glaucoma drops (dorzolamide-timolol) might decrease the amount of chronic swelling in patient with wet age-related macular degeneration who have been receiving anti-vascular endothelial growth factor (VEGF) injections. This will be a larger study where subjects are randomly assigned to receive the glaucoma drops or a placebo (artificial tears) in order to confirm whether this previous finding is valid. Subjects will continue to receive the normally scheduled anti-VEGF injections at regular intervals as done prior to enrollment. The only addition to the regimen will be the daily use of eye drops (dorzolamide-timolol or artificial tears) twice daily for the duration of the study. At the end of the study, the swelling in the retina will be compared to the amount before starting the drops to see if there is any difference between the group using dorzolamide-timolol versus artificial tears.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
12 days until next milestone

Study Start

First participant enrolled

February 8, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2019

Completed
12 months until next milestone

Results Posted

Study results publicly available

June 19, 2020

Completed
Last Updated

June 19, 2020

Status Verified

June 1, 2020

Enrollment Period

2 years

First QC Date

January 25, 2017

Results QC Date

May 24, 2020

Last Update Submit

June 5, 2020

Conditions

Neovascular Age-related Macular DegenerationWet Macular Degeneration

Keywords

neovascularwetage-relatedmacular degenerationdorzolamidetimolol

Outcome Measures

Primary Outcomes (1)

  • Change in Mean Central Subfield Thickness (CST)

    Change in mean CST on spectral domain optical coherence tomography from baseline to the final visit

    Baseline and 18 weeks

Secondary Outcomes (4)

  • Change in Mean Maximum Subretinal Fluid (SRF) Height

    Baseline and 18 weeks

  • Change in Mean Maximum Pigment Epithelial Detachment (PED) Height

    Baseline and 18 weeks

  • Change in Visual Acuity

    Baseline and 18 weeks

  • Change in Mean Intraocular Pressure (IOP)

    Baseline and 18 weeks

Study Arms (2)

Dorzolamide-timolol

ACTIVE COMPARATOR

Topical dorzolamide-timolol twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals.

Drug: Dorzolamide-timolol

Artificial tears

PLACEBO COMPARATOR

Topical artificial tears twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals.

Other: Artificial tears

Interventions

Dorzolamide-timololDRUG

Topical eye drop (active comparator) used twice daily for study duration

Also known as: Cosopt
Dorzolamide-timolol
Artificial tearsOTHER

Topical eye drop (placebo comparator) used twice daily for study duration

Artificial tears

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active choroidal neovascularization (CNV) due to AMD.
  • 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.
  • Baseline CST ≥ 270 µm on SD-OCT automated retinal thickness map.
  • Injection of the same anti-VEGF agent at each of the two visits immediately preceding study enrollment.
  • Time interval of 5 weeks (± 1 week) between visits for at least two visits immediately preceding study enrollment.
  • Subjects of either gender aged ≥ 45 years.
  • Provide written informed consent
  • Ability to comply with study and follow-up procedures and return for study visits.

You may not qualify if:

  • History of uveitis.
  • Presence of intraocular inflammation, significant epiretinal membrane (causing distortion of macular anatomy per investigator discretion), significant vitreomacular traction (per investigator discretion), macular hole, or vitreous hemorrhage.
  • Any ophthalmic surgery within previous 6 months, including cataract extraction.
  • Any history of vitrectomy or glaucoma surgery (e.g., trabeculectomy, tube shunt).
  • Current prescription eye drop usage (e.g., glaucoma drops, corticosteroid drops, etc.).
  • Any contraindication for topical use of a beta-blocker (e.g., bradycardia, decompensated heart failure, chronic obstructive pulmonary disease, reactive airway disease, asthma, etc.).
  • Any history of sulfonamide allergy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Palo Alto Medical Foundation

Palo Alto, California, 94301, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Associated Retinal Consultants

Royal Oak, Michigan, 48073, United States

Location

Mid Atlantic Retina- Wills Eye Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Retina Consultants of Houston

Houston, Texas, 77030, United States

Location

Related Publications (2)

  • 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: 26914218BACKGROUND

  • Hsu J, Patel SN, Wolfe JD, Shah CP, Chen E, Jenkins TL, Wibbelsman TD, Obeid A, Mikhail M, Garg SJ, Ho AC, Chiang A, Spirn MJ, Vander JF. Effect of Adjuvant Topical Dorzolamide-Timolol vs Placebo in Neovascular Age-Related Macular Degeneration: A Randomized Clinical Trial. JAMA Ophthalmol. 2020 May 1;138(5):560-567. doi: 10.1001/jamaophthalmol.2020.0724.

    PMID: 32239190DERIVED

MeSH Terms

Conditions

Wet Macular DegenerationMacular Degeneration

Interventions

dorzolamide-timolol combinationLubricant Eye Drops

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmic SolutionsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesLubricantsSpecialty Uses of Chemicals

Results Point of Contact

Title
Jason Hsu, MD
Organization
Wills Eye Physicians, Mid Atlantic Retina
research@midatlanticretina.com
215-928-3092

Study Officials

  • Jason Hsu, MD

    Wills Eye

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single-blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-director of Retina Research

Study Record Dates

First Submitted

January 25, 2017

First Posted

January 27, 2017

Study Start

February 8, 2017

Primary Completion

February 8, 2019

Study Completion

July 5, 2019

Last Updated

June 19, 2020

Results First Posted

June 19, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

US(5)