Safety Study of 2.0mg Lucentis to Treat Polypoidal Choroidal Vasculopathy
Part of paid clinical trials in Augusta, Georgia.
- Sponsor
- Southeast Retina Center, Georgia
- Study ID
- NCT01469156
- Phase
- PHASE1/PHASE2
- Status
- Completed
Conditions
- Polypoidal Choroidal Vasculopathy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- ranibizumab 0.5 or 2.0 mg/0.05 cc — DRUGranibizumab (3:1 ratio of 2mg:0.5 mg ranibizumab) administered in three initial monthly doses followed by a 9 month period of criteria-based, as-needed retreatment and 12 month off drug safety follow up.
Study Details
This Phase I/II study will investigate the safety and tolerability of intravitreally administered 0.5mg and 1.0 or 2.0mg Ranibizumab in three monthly doses followed by a 9 month period of criteria-based, as-needed retreatment and 12 month of drug safety follow up in subjects with exudative polypoidal choroidal vasculopathy (PCV) for a total of 24 months.
Key Dates
- First listed
- Nov 10, 2011
- Start date
- Sep 30, 2011
- Status verified
- Nov 2022
- Primary completion
- Feb 28, 2015
- Completion
- Feb 28, 2015
Study Design
- Enrollment
- 20 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Ranibizumab 1.0 or 2.0 mg (HIGH DOSE)Intraocular injection of 1.0 or 2.0 mg/0.05 cc ranibizumab. Photodynamic therapy with visudyne or laser photocoagulation or intravitreal steroids may be considered as monotherapy or in combination with Ranibizumab at the investigator's discretion if rescue criteria are met
- Active Comparator: Ranibizumab 0.5 mgIntraocular injection of 0.5 mg/0.05 cc ranibizumab. Photodynamic therapy with visudyne or laser photocoagulation or intravitreal steroids may be considered as monotherapy or in combination with Ranibizumab at the investigator's discretion if rescue criteria are met
Primary Outcome Measure
Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups. [ Time Frame: 2 years ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Southeast Retina Center | Augusta | Georgia | 30909 | - |
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