Trial Outcomes & Findings for Lucentis for Inflammatory Macular Edema Trial (NCT NCT00498355)

NCT ID: NCT00498355

Last Updated: 2017-11-30

Results Overview

The outcome measure was mean best spectacle-corrected visual acuity (BSCVA). In this study, BSCVA was measured after trial frame manifest refraction, using high-contrast modified Bailey-Lovie (ETDRS) charts at 4 meters. The charts were placed in a retro-illuminated light box equipped with two 20-watt fluorescent tubes. The highest attainable 4-meter visual acuity score is 100 letters.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 7 participants
• Primary outcome timeframe: baseline and 3 months
• Results posted on: 2017-11-30

Participant Flow

Patients were recruited from the F.I. Proctor Foundation Uveitis Clinica at University of California San Francisco.

Participant milestones

Measure	Ranibizumab for Macular Edema This study was an open-label, single-center, prospective, nonrandomized interventional case series of 7 eyes in 7 patients with controlled uveitis and persistent visually significant macular edema.
Overall Study STARTED	7
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Ranibizumab for Macular Edema This study was an open-label, single-center, prospective, nonrandomized interventional case series of 7 eyes in 7 patients with controlled uveitis and persistent visually significant macular edema.
Overall Study Lost to Follow-up	1

Baseline Characteristics

Lucentis for Inflammatory Macular Edema Trial

Baseline characteristics by cohort

Measure	Ranibizumab for Macular Edema n=7 Participants This study was an open-label, single-center, prospective, nonrandomized interventional case series of 7 eyes in 7 patients with controlled uveitis and persistent visually significant macular edema.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	47.4 years STANDARD_DEVIATION 15.96 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 3 months

Population: 6 patients completed all assessment points. One patient decided not to continue for nonmedical reasons, but they did complete the baseline, 1-week and 1-month assessment.

The outcome measure was mean best spectacle-corrected visual acuity (BSCVA). In this study, BSCVA was measured after trial frame manifest refraction, using high-contrast modified Bailey-Lovie (ETDRS) charts at 4 meters. The charts were placed in a retro-illuminated light box equipped with two 20-watt fluorescent tubes. The highest attainable 4-meter visual acuity score is 100 letters.

Outcome measures

Measure	Ranibizumab for Macular Edema n=6 Participants This study was an open-label, single-center, prospective, nonrandomized interventional case series of 7 eyes in 7 patients with controlled uveitis and persistent visually significant macular edema.
The Mean Change at 3 Months in BSCVA From Baseline	13 letters Interval 3.0 to 24.0

SECONDARY outcome

Timeframe: 6 to 12 months

Outcome measures

Measure	Ranibizumab for Macular Edema n=5 Participants This study was an open-label, single-center, prospective, nonrandomized interventional case series of 7 eyes in 7 patients with controlled uveitis and persistent visually significant macular edema.
The Median Change in Best Corrected Visual Acuity From 6 to12 Months	-2 Letters Interval -6.0 to 2.0

SECONDARY outcome

Timeframe: 7 days, and at months 3, 6, 9, and 12

Outcome measures

Measure	Ranibizumab for Macular Edema n=7 Participants This study was an open-label, single-center, prospective, nonrandomized interventional case series of 7 eyes in 7 patients with controlled uveitis and persistent visually significant macular edema.
The Mean Change in Foveal Retinal Thickness From Baseline at 7 Days, and at Months 3, 6, 9, and 12 Week 7	-267 microns Interval -620.0 to -158.0
The Mean Change in Foveal Retinal Thickness From Baseline at 7 Days, and at Months 3, 6, 9, and 12 Month 3	-356 microns Interval -1034.0 to -95.0
The Mean Change in Foveal Retinal Thickness From Baseline at 7 Days, and at Months 3, 6, 9, and 12 Month 6	-354 microns Interval -1053.0 to -85.0
The Mean Change in Foveal Retinal Thickness From Baseline at 7 Days, and at Months 3, 6, 9, and 12 Month 9	-243 microns Interval -941.0 to 222.0
The Mean Change in Foveal Retinal Thickness From Baseline at 7 Days, and at Months 3, 6, 9, and 12 Month 12	-388 microns Interval -1026.0 to 12.0

SECONDARY outcome

Timeframe: Study duration

Outcome measures

Measure	Ranibizumab for Macular Edema n=7 Participants This study was an open-label, single-center, prospective, nonrandomized interventional case series of 7 eyes in 7 patients with controlled uveitis and persistent visually significant macular edema.
The Incidence of Uveitis Flares (> 2+ Cells in the Anterior Chamber or Vitreous)	0 uveitis flares

SECONDARY outcome

Timeframe: Study duration

Outcome measures

Measure	Ranibizumab for Macular Edema n=7 Participants This study was an open-label, single-center, prospective, nonrandomized interventional case series of 7 eyes in 7 patients with controlled uveitis and persistent visually significant macular edema.
The Incidence of Ocular and Non-ocular Adverse Events	4 adverse events

Adverse Events

Ranibizumab for Macular Edema

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ranibizumab for Macular Edema n=7 participants at risk This study was an open-label, single-center, prospective, nonrandomized interventional case series of 7 eyes in 7 patients with controlled uveitis and persistent visually significant macular edema.
Eye disorders Subconjunctival Hemorrhage	57.1% 4/7 • Number of events 4 • 12 months

Additional Information

Dr. Nisha Acharya

University of California San Francisco

Phone: 415-476-8131

Email: nisha.acharya@ucsf.edu

Results disclosure agreements

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