Trial Outcomes & Findings for Pilot Study of Ranibizumab (Lucentis) for Uveitic Cystoid Macular Edema (NCT NCT00826618)

Results Overview

Mean change in best corrected visual acuity (assessed by the ETDRS chart at 4 m) from baseline at 12 months following first intravitreal injection of ranibizumab was 12.2 ETDRS letters (P = 0.015).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

6 participants

Primary outcome timeframe

1 year

Results posted on

2014-08-26

Participant Flow

Participant milestones

Participant milestones
Measure	Ranibizumab ranibizumab: This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME.
Overall Study STARTED	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Ranibizumab ranibizumab: This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Pilot Study of Ranibizumab (Lucentis) for Uveitic Cystoid Macular Edema

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ranibizumab n=5 Participants ranibizumab: This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME.
Age, Continuous	54 years STANDARD_DEVIATION 19 • n=99 Participants
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=99 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants
Sex: Female, Male Female	2 Participants n=99 Participants
Sex: Female, Male Male	3 Participants n=99 Participants
Region of Enrollment United States	5 participants n=99 Participants

PRIMARY outcome

Timeframe: 1 year

Mean change in best corrected visual acuity (assessed by the ETDRS chart at 4 m) from baseline at 12 months following first intravitreal injection of ranibizumab was 12.2 ETDRS letters (P = 0.015).

Outcome measures

Outcome measures
Measure	Ranibizumab n=5 Participants ranibizumab: This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME. Mean change in BCVA (assessed by the ETDRS chart at 4 m) from baseline at 12 months was 12.2 ETDRS letters (P = 0.015).
Change From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS at 4 Meters) at 12 Months.	12.2 Change in ETDRS Letters Standard Deviation 6.7

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

Adverse Events

Ranibizumab

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ranibizumab n=5 participants at risk ranibizumab: This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME.
Eye disorders Floaters	60.0% 3/5
Eye disorders Eye Pain	40.0% 2/5
Eye disorders Blurry Vision	40.0% 2/5
Eye disorders Uveitis in fellow eye	40.0% 2/5
Eye disorders Anterior uveitis	20.0% 1/5
Eye disorders Dry Eye	20.0% 1/5
Eye disorders Cataract	20.0% 1/5
Eye disorders Glaucoma	20.0% 1/5
Eye disorders Ocular pruritis	20.0% 1/5
Cardiac disorders Tachycardia	20.0% 1/5

Additional Information

Thomas A. Albini, MD

University of Miami

Phone: 3054825006

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place