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OpenTrials
Completed

NCT Number: NCT02571972

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Wills Eye Hospital / Mid Atlantic Retina

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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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Treatment and study plan

Dorzolamide-timolol

Drug

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

Other names: Cosopt

Primary outcomes

  1. Mean Central Subfield Thickness (CST)

    Time frame: 3 visits (8-12 weeks)

    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

Secondary outcomes

  1. Visual Acuity

    Time frame: 3 visits (8-12 weeks)

    LogMAR Visual acuity on enrollment and final visit

  2. Maximum Subretinal Fluid Height

    Time frame: 3 visits (8-12 weeks)

    Measurement based on SD-OCT

  3. Maximum Pigment Epithelial Detachment Height

    Time frame: 3 visits (8-12 weeks)

    Measurement based on SD-OCT

Sponsors and collaborators

Lead sponsor

Wills Eye

Other

Collaborators

  • J. Arch McNamara Research Fund
  • Mid Atlantic Retina

Registry information

Official study 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).

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 8, 2015
Registry last updated
Dec 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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