Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab (2.0mg) Prospectively
Overview
- Phase
- Phase 1
- Intervention
- ranibizumab 2.0mg
- Conditions
- Polypoidal Choroidal Vasculopathy
- Sponsor
- Retina Consultants of Hawaii
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- To evaluate the efficacy of intravitreal injections of 2.0mg ranibizumab administered monthly in preventing vision loss
- Last Updated
- 15 years ago
Overview
Brief Summary
Monthly, continuous anti-vegf therapy for patients presenting with active polypoidal choroidal vasculopathy. Two arms, treatment naive and previously treated with an FDA approved anti-VEGF therapy, will be randomized and dosed with open label 2.0mg ranibizumab.
Detailed Description
Patients will be followed with spectral oct, 4m BCVA, ICG, FA and monthly eye examinations for one year.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study
- •Age \>= 25 years
- •Polypoidal choroidal vasculopathy as noted on fluorescein and ICG angiography: active leakage, active bleeding or recent decrease in vision
- •BVCA using ETDRS of 20/32 to 20/400
Exclusion Criteria
- •Any history of prior vitrectomy
- •Any prior treatment with verteporfin PDT in the study eye
- •Previous cataract surgery within the preceding 2 months of D0
- •Active intraocular inflammation in the study eye
- •Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- •A condition, that in the opinion of the investigator, would preclude participation in the study (e.g. unstable medical status including blood pressure, cardiovascular disease)
- •Participation in another investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry.
- •Prior anti-VEGF (Macugen, Avastin, Lucentis) in the study eye within 30 days prior to enrollment in this study
- •Known allergy to any component in the study drug
- •Uncontrolled hypertension: \>180/110
Arms & Interventions
Previously Treated
With prior anti-vegf therapy, only, no sooner than 30 days prior to enrollment into trial
Intervention: ranibizumab 2.0mg
Treatment-Naive
Treatment-Naive: no previous treatment for PCV
Intervention: ranibizumab 2.0mg
Outcomes
Primary Outcomes
To evaluate the efficacy of intravitreal injections of 2.0mg ranibizumab administered monthly in preventing vision loss
Time Frame: 1 year
To evaluate the efficacy of intravitreal injections of 2.0mg ranibizumab administered monthly in preventing vision loss, as measured by calculating the mean change in VA from baseline to Month 12
Secondary Outcomes
- To evaluate the safety and tolerability of intravitreal injections of 2.0mg ranibizumab administered monthly(1 year)
- To evaluate the efficacy of monthly intravitreal injections of 2.0mg ranibizumab in preventing vision loss(1 year)
- To investigate the efficacy of monthly intravitreal injections of 2.0mg ranibizumab on clinical findings associated with PCV(1 year)