Phase 3
N=66
Extended Follow-up of Patients With Macular Edema Due to Retinal Vein Occlusion
Retinal Vein Occlusion
Bottom Line
View on ClinicalTrials.gov: NCT01198327 ↗Enrolled (actual)
66
Serious AEs
25.8%
Results posted
Jan 2014
Primary outcome: Primary: Incidence of Serious Adverse Events. — 17 number of serious adverse events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ranibizumab (Drug); Peripheral Laser (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Peter A Campochiaro, MD
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Serious Adverse Events. |
17 | — |
| SECONDARY Mean Changes in Visual Acuity |
14.0; 20.1 | — |
| SECONDARY Mean Change in Retinal Thickness |
-426.0; -236.2 | — |
Summary
This study evaluates long-term safety in patients with macular edema due to Retinal Vein Occlusion (RVO) originally enrolled in the BRAVO & CRUISE trials and subsequently followed in the HORIZON extension trial.
Eligibility Criteria
Inclusion Criteria
- Signed informed consent and authorization of use and disclosure of protected health information
- Age greater than or equal to 18 years
- Completion of 12 months in BRAVO or CRUISE trials, with subsequent follow-up in the HORIZON extension study. Exit from HORIZON should be within 90 days of enrollment
Exclusion Criteria
- Pregnancy (positive pregnancy test) or lactation
- Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
- Any condition that the investigator believes would pose a significant hazard to the subject if investigational therapy were initiated.
- Inability to comply with study or follow up procedures
- Participation in another simultaneous medical investigation or trial
Data sourced from ClinicalTrials.gov (NCT01198327). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.