Trial Outcomes & Findings for Sildenafil for Treatment of Choroidal Ischemia (NCT NCT04356716)

Last Updated: 2025-07-04

Results Overview

Patients are evaluated for progression of disease/dystrophy via visual acuity (improved/stable/worsened) and appearance of fluid layer and drusen on OCT testing.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

Up to 63 months

Results posted on

2025-07-04

Participant Flow

Participant milestones

Participant milestones
Measure	Sildenafil Participants are prescribed sildenafil 40-80 mg daily.	Medical Record Review Medical record review for participants that are prescribed Sildenafil off-label as part of standard of care treatment for disease.
Overall Study STARTED	21	1
Overall Study COMPLETED	21	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sildenafil for Treatment of Choroidal Ischemia

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Up to 63 months

Patients are evaluated for progression of disease/dystrophy via visual acuity (improved/stable/worsened) and appearance of fluid layer and drusen on OCT testing.

Outcome measures

Outcome measures
Measure	Sildenafil n=21 Participants Participants are prescribed sildenafil 40-80 mg daily.
Change in Visual Acuity (Sildenafil Group) Right eyes	0.00 logMAR Standard Deviation 0.21
Change in Visual Acuity (Sildenafil Group) Left eyes	-0.03 logMAR Standard Deviation 0.36

PRIMARY outcome

Timeframe: 22 months

Patients are evaluated for progression of disease/dystrophy via visual acuity (improved/stable/worsened) and appearance of fluid layer and drusen on OCT testing.

Outcome measures

Outcome measures
Measure	Sildenafil n=1 Participants Participants are prescribed sildenafil 40-80 mg daily.
Change in Visual Acuity (Medical Record Review Group) Right eye	0.00 logMAR
Change in Visual Acuity (Medical Record Review Group) Left eye	0.00 logMAR

Adverse Events

Sildenafil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Medical Record Review

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Suzanne Daly, RN, BSN

Columbia University

Phone: 212 305 9535

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Sildenafil n=21 Participants Participants are prescribed sildenafil 40-80 mg daily.	Medical Record Review n=1 Participants Medical record review for participants that are prescribed Sildenafil off-label as part of standard of care treatment for disease.	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	1 Participants n=7 Participants	15 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	0 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	1 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	0 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	1 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	0 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	1 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	0 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	1 participants n=7 Participants	22 participants n=5 Participants