Trial Outcomes & Findings for Effects of Sildenafil on Choroidal Thickness in AMD (NCT NCT01830790)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Baseline, 1 hour, and 3 hours post-treatment

Results posted on

2015-06-23

Participant Flow

Participant milestones

Participant milestones
Measure	Healthy Controls Healthy individuals \>65 years old without ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness Sildenafil citrate: Single dose of 100mg Sildenafil citrate	AMD Patients Age-related macular degeneration (AMD) patients \>65 years old without other ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness Sildenafil citrate: Single dose of 100mg Sildenafil citrate
Overall Study STARTED	0	10
Overall Study COMPLETED	0	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Sildenafil on Choroidal Thickness in AMD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Controls Healthy individuals \>65 years old without ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness Sildenafil citrate: Single dose of 100mg Sildenafil citrate	AMD Patients n=10 Participants Age-related macular degeneration (AMD) patients \>65 years old without other ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness Sildenafil citrate: Single dose of 100mg Sildenafil citrate	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 participants n=7 Participants	0 participants n=5 Participants
Age, Categorical Between 18 and 65 years	—	2 participants n=7 Participants	2 participants n=5 Participants
Age, Categorical >=65 years	—	8 participants n=7 Participants	8 participants n=5 Participants
Gender Female	—	4 participants n=7 Participants	4 participants n=5 Participants
Gender Male	—	6 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 1 hour, and 3 hours post-treatment

Population: Study was terminated early due to inadequate support to complete recruitment/data analysis. No outcome measure data was collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 1hour, and 3 hours post-treatment

Population: Study was terminated early due to inadequate support to complete recruitment/data analysis. No outcome measure data was collected.

Outcome measures

Outcome data not reported

Adverse Events

Healthy Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AMD Patients

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

Sharon Fekrat: Associate Professor of Ophthalmology

Duke University

Phone: (919) 681-0341

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place