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Sildenafil for Treatment of Choroidal Ischemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04356716
Recruitment Status : Recruiting
First Posted : April 22, 2020
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Donald Coleman, Columbia University

Brief Summary:
The hypothesis of this study is to determine if there is a benefit afforded by the use of systemic Sildenafil to patients with choroidal and retinal degenerations and dystrophies, such as vitelliform degeneration, dry and reticular age-related macular degeneration (AMD) as well as patients with hereditary and acquired retinal dystrophies such as retinitis pigmentosa and central serous retinopathy.

Condition or disease Intervention/treatment Phase
Choroidal Ischemia Vitelliform Macular Dystrophy Age-related Macular Degeneration Central Serous Retinopathy Retinitis Pigmentosa Drug: Sildenafil Other: Standard of Care Sildenafil Diagnostic Test: Ocular Coherence Tomography-Angiography (OCT-A) Other: Visual Acuity (VA) Phase 2

Detailed Description:
Age-Related Macular Degeneration (AMD) is a sight-threatening visual disturbance that affects the macula in older ages. It is irreversible if the pigment epithelium is lost (dry AMD), but wet AMD can be arrested or delayed with the use of intraocular injections of one of 3 different compounds. All three drugs are injected into the eye in minute doses of usually 0.1 ml. These are usually injected at 4 to 6 week intervals and treatment may be extended for several years. Different patterns of injection times are followed but usually are monthly for 12 or more months, or monthly for 3 months and then extended observation at one to two month intervals unless vision (visual acuity) declines or Optical Coherence Tomography-angiography (OCT-A) shows recurrence of fluid or increase in size or amount of drusen (deposits of lipofuscin) in the retina. Vitelliform macular degeneration is a disorder that causes visual loss due to drusen in the macula, which have been shown to be identical to the deposits seen in macular degeneration. The goal of therapy in this proposal is to use sildenafil to increase choroidal blood flow to treat dry AMD and slow the progression of visual loss in vitelliform and age-related dry AMD as well as other macular, retinal and choroidal degenerations and dystrophies, as well as reduce or eliminate the number of injections required by slowing down transformation of dry AMD to wet AMD in treated patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are assigned to the investigational sildenafil arm with a dose of 40-80mg daily, or the records review arm when taking sildenafil off-label.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sildenafil for Treatment of Choroidal Ischemia
Actual Study Start Date : November 11, 2014
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021


Arm Intervention/treatment
Active Comparator: Standard of Care Sildenafil
Medical record review for participants that are prescribed Sildenafil off-label as part of standard of care treatment for disease.
Other: Standard of Care Sildenafil
Medical record review of participants that receive Sildenafil as part of standard of care.
Other Names:
  • Viagra
  • Revatio

Active Comparator: Sildenafil
Participants are prescribed sildenafil 40-80 mg daily.
Drug: Sildenafil
Initial Sildenafil dosage will be weight dependent. Participants will start at 40 mg daily (20mg in the morning, 20 mg in the evening) or 60 mg daily (40mg in the morning and 20 mg in the evening). Sildenafil dosage may be increased to up to 80mg daily (20-40mg in the morning and 20-40mg in the evening) based on the response to lower doses. If the participant has not had improvement after initial treatment, the dose may be increased, at the discretion of the study physician.
Other Names:
  • Viagra
  • Revatio

Diagnostic Test: Ocular Coherence Tomography-Angiography (OCT-A)
Retinal photographs will be taken at each study visit.

Other: Visual Acuity (VA)
Visual acuity will be measured with Snellen Eye Chart at each study visit.




Primary Outcome Measures :
  1. Change in Choroidal Perfusion [ Time Frame: Up to 5 Years ]
    Patients are evaluated for progression of disease/dystrophy via visual acuity (improved/stable/worsened) and appearance of fluid layer and drusen on OCT testing.



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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:

  • Diagnosis of retinal and choroidal degenerations (reticular or vitelliform AMD or vitelliform-type subretinal drusen) or hereditary or acquired retinal dystrophies (retinitis pigmentosa or central serous retinopathy)

Exclusion Criteria:

  • Diagnosis of heart disease requiring use of nitrates
  • Inability to be examined monthly or bi-monthly

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): NCT04356716


Contacts
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Contact: Suzanne Daly, RN, BSN sd2798@cumc.columbia.edu

Locations
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United States, New York
Columbia University Medical Center, Edward Harkness Eye Institute Recruiting
New York, New York, United States, 10032
Contact: Suzanne Daly, RN,BSN       sd2798@cumc.columbia.edu   
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Donald Jackson Coleman, MD Columbia University
Publications:
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Responsible Party: Donald Coleman, Professor of Ophthalmology, Columbia University
ClinicalTrials.gov Identifier: NCT04356716    
Other Study ID Numbers: AAAM7406
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Donald Coleman, Columbia University:
Sildenafil
Viagra
Revatio
Additional relevant MeSH terms:
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Macular Degeneration
Retinitis
Retinitis Pigmentosa
Central Serous Chorioretinopathy
Vitelliform Macular Dystrophy
Ischemia
Pathologic Processes
Retinal Degeneration
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Genetic Diseases, Inborn
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents