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Trial Outcomes & Findings for Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial (NCT NCT00363168)

NCT ID: NCT00363168

Last Updated: 2012-10-19

Results Overview

Visual acuity measured prior to first treatment with ranibizumab and at 12 months following the first treatment were compared for each subject enrolled in the study. The 12 month follow-up visual acuity was subtracted from the baseline visual acuity. Avoiding a 15 or more letter loss in visual acuity was considered a successful outcome.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

7 participants

Primary outcome timeframe

12 months

Results posted on

2012-10-19

Participant Flow

Participant milestones

Participant milestones
Measure
Ranibizumab Dose A
0.3 mg/0.05 ml intravitreal injection
Ranibizumab Dose B
0.5 mg/0.05 ml intravitreal injection
Overall Study
STARTED
5
2
Overall Study
COMPLETED
5
2
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Ranibizumab Dose A
n=5 Participants
0.3 mg/0.05 ml intravitreal injection
Ranibizumab Dose B
n=2 Participants
0.5 mg/0.05 ml intravitreal injection
Total
n=7 Participants
Total of all reporting groups
Region of Enrollment
United States
5 participants
n=5 Participants
2 participants
n=7 Participants
7 participants
n=5 Participants
Sex: Female, Male
Female
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
Sex: Female, Male
Male
3 Participants
n=5 Participants
2 Participants
n=7 Participants
5 Participants
n=5 Participants
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
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Age, Categorical
>=65 years
4 Participants
n=5 Participants
2 Participants
n=7 Participants
6 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Visual acuity measured prior to first treatment with ranibizumab and at 12 months following the first treatment were compared for each subject enrolled in the study. The 12 month follow-up visual acuity was subtracted from the baseline visual acuity. Avoiding a 15 or more letter loss in visual acuity was considered a successful outcome.

Outcome measures

Outcome measures
Measure
Ranibizumab Dose A
n=5 Participants
0.3 mg/0.05 ml intravitreal injection
Ranibizumab Dose B
n=2 Participants
0.5 mg/0.05 ml intravitreal injection
Number of Subjects Avoiding 15 or More Letter Loss of Best Corrected Visual Acuity From Baseline to 12 Months on an Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Chart Measured at 4 Meters.
5 participants
2 participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months after last injection

Potential complications included: * Deterioration of best-corrected visual acuity by 3 or more lines * Development of intraocular inflammation * Development of elevated intraocular pressure * Development of other ocular or systemic adverse effects. Subjects were monitored for potential drug-related ocular adverse effects: intraocular inflammation (uveitis), endophthalmitis, central retinal vein occlusion, transient elevation of IOP, acute reduction in the visual acuity, vitreous hemorrhage, injection-site pain, retinal hemorrhage, posterior vitreous detachment, and subconjunctival hemorrhage. Subjects were monitored for potential adverse effects of intravitreal injections: crystalline lens penetration, retinal break and/or detachment, vitreous hemorrhage, inflammation, and infection. Potential systemic adverse effects were captured by monitoring vital functions such as cardiovascular function, nervous system function, renal function, and gastrointestinal function.

Outcome measures

Outcome measures
Measure
Ranibizumab Dose A
n=5 Participants
0.3 mg/0.05 ml intravitreal injection
Ranibizumab Dose B
n=2 Participants
0.5 mg/0.05 ml intravitreal injection
Number of Subjects Experiencing Complications Related to Drug or Its Administration
0 participants
0 participants

Adverse Events

Ranibizumab Dose A

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Ranibizumab Dose B

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

Neil M. Bressler

Johns Hopkins University

Phone: 410-955-8342

Results disclosure agreements

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