Trial Outcomes & Findings for Lucentis (Ranibizumab) for Eales' Disease (NCT NCT00384449)

NCT ID: NCT00384449

Last Updated: 2019-06-11

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 1 participants
• Primary outcome timeframe: Baseline and 6 months
• Results posted on: 2019-06-11

Participant Flow

Participant milestones

Measure	Lucentis (Ranibizumab) Three monthly intravitreal injections of 0.5 mg ranibizumab
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lucentis (Ranibizumab) for Eales' Disease

Baseline characteristics by cohort

Measure	Lucentis (Ranibizumab) n=1 Participants Three monthly intravitreal injections of 0.5 mg ranibizumab
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: A patient was enrolled, but then became ineligible. The same patient was later re-enrolled and maintained eligibility.

Outcome measures

Measure	Lucentis (Ranibizumab) n=1 Participants Lucentis (ranibizumab) Ranibizumab: Consented, enrolled subjects will receive open-label intravitreal injections of 0.5 mg ranibizumab administered once a month for 3 months
Change in OCT Thickness. Baseline, Day 0	269 um
Change in OCT Thickness. Month 6	262 um

PRIMARY outcome

Timeframe: Monthly through Month 6

Population: A patient was enrolled, but then became ineligible. The same patient was later re-enrolled and maintained eligibility.

Outcome measures

Measure	Lucentis (Ranibizumab) n=1 Participants Lucentis (ranibizumab) Ranibizumab: Consented, enrolled subjects will receive open-label intravitreal injections of 0.5 mg ranibizumab administered once a month for 3 months
Incidence and Severity of Ocular Adverse Events, as Identified by Eye Examination (Including Visual Acuity Testing)	0 adverse events

PRIMARY outcome

Timeframe: Monthly through Month 6

Population: A patient was enrolled, but then became ineligible. The same patient was later re-enrolled and maintained eligibility.

No adverse events.

Outcome measures

Measure	Lucentis (Ranibizumab) n=1 Participants Lucentis (ranibizumab) Ranibizumab: Consented, enrolled subjects will receive open-label intravitreal injections of 0.5 mg ranibizumab administered once a month for 3 months
Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs	0 adverse events

SECONDARY outcome

Timeframe: Months 3,4,5 and 6

Population: A patient was enrolled, but then became ineligible. The same patient was later re-enrolled and maintained eligibility.

Outcome measures

Measure	Lucentis (Ranibizumab) n=1 Participants Lucentis (ranibizumab) Ranibizumab: Consented, enrolled subjects will receive open-label intravitreal injections of 0.5 mg ranibizumab administered once a month for 3 months
BCVA, as Assessed by the Number of Letters Read Correctly on the ETDRS Eye Chart at a Starting Test Distance of 4 Meters. Month 3	63 letters
BCVA, as Assessed by the Number of Letters Read Correctly on the ETDRS Eye Chart at a Starting Test Distance of 4 Meters. Month 4	70 letters
BCVA, as Assessed by the Number of Letters Read Correctly on the ETDRS Eye Chart at a Starting Test Distance of 4 Meters. Month 5	64 letters
BCVA, as Assessed by the Number of Letters Read Correctly on the ETDRS Eye Chart at a Starting Test Distance of 4 Meters. Month 6	60 letters

SECONDARY outcome

Timeframe: Monthly through Month 6

No adverse events.

Outcome measures

Measure	Lucentis (Ranibizumab) n=1 Participants Lucentis (ranibizumab) Ranibizumab: Consented, enrolled subjects will receive open-label intravitreal injections of 0.5 mg ranibizumab administered once a month for 3 months
Incidence of Ocular and Non-ocular Adverse Events Evaluated Through Month 6.	0 adverse events

Adverse Events

Lucentis (Ranibizumab)

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

Dr. Christina J. Flaxel

Oregon Health & Science University

Phone: (503) 418-3352

Email: flaxelc@ohsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place