Trial Outcomes & Findings for Effectiveness and Safety of Topical Ranibizumab for Treatment of Corneal Neovascularization (NV) (NCT NCT00681889)

Results Overview

Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

9 participants

Primary outcome timeframe

16 Weeks

Results posted on

2012-11-08

Participant Flow

Patients were recruited from the Cornea Service at the Massachusetts Eye and Ear Infirmary from April 2008 through September 2009.

Participants were assigned to the investigational treatment upon a full eligibility screening. Participants were not eligible if they had received investigational therapy within 60 days, received treatment with anti-VEGF agents (intraocular or systemic) within 45 days, were concurrently using systemic anti-VEGF agents amongst other criteria.

Participant milestones

Participant milestones
Measure	Treatment Arm 10 eyes of 9 patients will receive treatment (Ranibizumab) Ranibizumab : 10 eyes of 9 patients will receive treatment (Ranibizumab)
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness and Safety of Topical Ranibizumab for Treatment of Corneal Neovascularization (NV)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Arm n=9 Participants 10 Patients will receive treatment (Ranibizumab) Ranibizumab : 10 Patients will receive treatment (Ranibizumab)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age Continuous	57.3 years STANDARD_DEVIATION 14.5 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 16 Weeks

Population: All participants enrolled into the study were analyzed.

Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing

Outcome measures

Outcome measures
Measure	Treatment Arm n=9 Participants 9 Patients will receive treatment (Ranibizumab) Ranibizumab : 9 Patients will receive treatment (Ranibizumab)
Incidence and Severity of Ocular Adverse Event	0 participants

PRIMARY outcome

Timeframe: 16 Weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Prospective

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Prospective

Outcome measures

Outcome data not reported

Adverse Events

Treatment Arm

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. Reza Dana

Massachusetts Eye and Ear Infirmary

Phone: 617-573-3313

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place