Trial Outcomes & Findings for Ranibizumab in Preventing Failure of Ahmed Valve Glaucoma Surgery (NCT NCT00644280)

Results Overview

Criteria for success at 6 months postoperatively was intraocular pressure (IOP) \< 18mmHg without the necessity for adjunctive medication for pressure or IOP \< 15mmHg with \<=1 adjunctive medication.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

6 months

Results posted on

2022-08-02

Participant Flow

Patients were recruited from the University of California, San Francisco (UCSF) Glaucoma Service

Participant milestones

Participant milestones
Measure	Ranibizumab Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery	Usual Care Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
Overall Study STARTED	6	5
Overall Study COMPLETED	6	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ranibizumab in Preventing Failure of Ahmed Valve Glaucoma Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ranibizumab n=6 Participants Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery	Usual Care n=5 Participants Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Criteria for success at 6 months postoperatively was intraocular pressure (IOP) \< 18mmHg without the necessity for adjunctive medication for pressure or IOP \< 15mmHg with \<=1 adjunctive medication.

Outcome measures

Outcome measures
Measure	Ranibizumab n=6 Participants Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery	Usual Care n=5 Participants Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
Tube Success at 6 Months	83 percentage of participants	40 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Participants experiencing significant ocular adverse events, including endophthalmitis and rhegmatogenous retinal detachment

Outcome measures

Outcome measures
Measure	Ranibizumab n=6 Participants Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery	Usual Care n=5 Participants Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
Significant Ocular Adverse Events	0 participants	0 participants

Adverse Events

Ranibizumab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

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

Shan C. Lin, MD

University of California San Francisco

Phone: 415-353-2608

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place