Trial Outcomes & Findings for To Study the Effectiveness and Safety of Niacin and a Topical Steroid Eye Drop to Treat Retinal Vein Occlusions (NCT NCT00493064)

Results Overview

improvement with combination of niacin and topical prednisolone acetate

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

63 participants

Primary outcome timeframe

one year

Results posted on

2018-12-21

Participant Flow

Participant milestones

Participant milestones
Measure	Prospective Active Treatment Niacin 500mg TID PO for treatment of retinal vein occlusions. Nicotinic acid: topical eye drops Prednisolone acetate: topical eye drops
Overall Study STARTED	63
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

To Study the Effectiveness and Safety of Niacin and a Topical Steroid Eye Drop to Treat Retinal Vein Occlusions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prospective Active Treatment n=63 Participants Niacin 500mg TID PO for treatment of retinal vein occlusions. Nicotinic acid: topical eye drops Prednisolone acetate: topical eye drops
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	49 Participants n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants
Region of Enrollment United States	63 Participants n=5 Participants

PRIMARY outcome

Timeframe: one year

improvement with combination of niacin and topical prednisolone acetate

Outcome measures

Outcome measures
Measure	Prospective Active Treatment n=63 Participants Niacin 500mg TID PO for treatment of retinal vein occlusions. Nicotinic acid: topical eye drops Prednisolone acetate: topical eye drops
Number of Participants With An Improvement in Vision, as Measured by an Increase of 15 Letters on the Early Treatment Diabetic Retinopathy Study (EDTRS) Vision Chart.	63 Participants

SECONDARY outcome

Timeframe: one year

Population: Although data for this outcome measure was collected, however, data are not available. The PI is retired and no longer works in the organization. Sincere efforts were made to obtain the data, however, no data are available for this outcome.

data not available

Outcome measures

Outcome data not reported

Adverse Events

Prospective Active Treatment

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

Renee Kaneshiro, study coordinator

PaloAltoMF

Phone: 650-853-4744

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place