Sildenafil for Treatment of Choroidal Ischemia
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|ClinicalTrials.gov Identifier: NCT04356716|
Recruitment Status : Recruiting
First Posted : April 22, 2020
Last Update Posted : April 22, 2020
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|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)|
|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|
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.
Active Comparator: Sildenafil
Participants are prescribed sildenafil 40-80 mg daily.
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.
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.
- 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.
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
|Contact: Suzanne Daly, RN, BSNfirstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Donald Jackson Coleman, MD||Columbia University|