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Trial record 1 of 23 for:    Macular Degeneration, Wet | Philadelphia, Pennsylvania, U.S.
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Dorzolamide-timolol Drops With Injections to Treat AMD,RVO or DME.

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ClinicalTrials.gov Identifier: NCT02571972
Recruitment Status : Completed
First Posted : October 8, 2015
Last Update Posted : April 19, 2018
Sponsor:
Collaborators:
J. Arch McNamara Research Fund
Mid Atlantic Retina
Information provided by (Responsible Party):
Jason Hsu, MD, Wills Eye

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.

Condition or disease Intervention/treatment Phase
Wet Macular Degeneration Age-related Macular Degeneration Diabetic Macular Edema Retinal Vein Occlusion Drug: Dorzolamide-timolol Phase 2

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Topical Aqueous Suppressant on Anatomic and Functional Response to Intravitreal Anti-vascular Endothelial Growth Factor Injections in Age-related Macular Degeneration, Retinal Vein Occlusions or Diabetic Macular Edema.
Actual Study Start Date : October 1, 2014
Actual Primary Completion Date : July 10, 2017
Actual Study Completion Date : December 1, 2017


Arm Intervention/treatment
Experimental: Dorzolamide-timolol
  • 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
On enrollment, eligible patients will be started on topical dorzolamide-timolol in the study eye twice daily for the study duration
Other Name: Cosopt




Primary Outcome Measures :
  1. Mean central macular thickness (CMT) [ Time Frame: 3 visits (8-12 weeks) ]
    Mean central retinal thickness (CMT) on SD-OCT on 1 visit prior to enrollment and all visits subsequent to study enrollment


Secondary Outcome Measures :
  1. Visual acuity [ Time Frame: 3 visits (8-12 weeks) ]
    Visual acuity

  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02571972


Locations
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United States, Pennsylvania
Wills Eye Hospital / Mid Atlantic Retina
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Wills Eye
J. Arch McNamara Research Fund
Mid Atlantic Retina
Investigators
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Principal Investigator: Jason Hsu, MD Wills Eye Hospital, Mid Atlantic Retina

Publications:
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Responsible Party: Jason Hsu, MD, PI, Wills Eye
ClinicalTrials.gov Identifier: NCT02571972     History of Changes
Other Study ID Numbers: IRB#14-435
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Manuscript is under development. Age-related macular degeneration data published JAMA Ophthalmol. 2016 Apr;134(4):437-43. doi: 10.1001/jamaophthalmol.2016.0045. Topical Dorzolamide-Timolol With Intravitreous Anti-Vascular Endothelial Growth Factor for Neovascular Age-Related Macular Degeneration.

Sridhar J1, Hsu J1, Shahlaee A1, Garg SJ1, Spirn MJ1, Fineman MS1, Vander J1. PMID: 26914218 DOI: 10.1001/jamaophthalmol.2016.0045


Keywords provided by Jason Hsu, MD, Wills Eye:
dorzolamide-timolol
topical aqueous suppression
neovascular age-related macular degeneration
macular edema
intravitreal injection
anti-vascular endothelial growth factor

Additional relevant MeSH terms:
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Macular Degeneration
Macular Edema
Wet Macular Degeneration
Retinal Degeneration
Edema
Retinal Vein Occlusion
Signs and Symptoms
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Timolol
Dorzolamide
Endothelial Growth Factors
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Growth Substances
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors