Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab Prospectively
Overview
- Phase
- Phase 1
- Intervention
- high-dose ranibizumab
- Conditions
- PCV
- Sponsor
- Hawaii Pacific Health
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- BCVA
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This is a 24-month study of ranibizumab (2.0 mg and 1.0 mg) in subjects with polypoidal choroidal vasculopathy as diagnosed by fluorescein/indocyanine green (FA/ICG) angiography.
Investigators
Gregg T. Kokame, MD
Medical Director, The Retina Center at Pali Momi
Hawaii Pacific Health
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
- •BCVA using ETDRS of 20/32 to 20/400
Exclusion Criteria
- •Any history of previous vitrectomy
- •Any prior treatment with verteporfin photodynamic therapy in the study eye.
- •Previous cataract surgery within the preceding 2 months of Day 0
- •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 an 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-vascular endothelial growth factor (VEGF) (Macugen, Avastin, Lucentis) in the study eye prior within 30 days prior to enrollment in this study
- •Known allergy to any component of the study drug
- •Blood pressure \>180/110 (systolic above 180 or diastolic above 110) If blood pressure if brought below 180/110 by anti-hypertensive treatment, the patient can become eligible.
Arms & Interventions
Cohort 1
12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab
Intervention: high-dose ranibizumab
Cohort 1
12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab
Intervention: ranibizumab
Cohort 2
6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg
Intervention: high-dose ranibizumab
Cohort 2
6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg
Intervention: ranibizumab
Cohort 3
24 months of monthly, intravitreal injections of ranibizumab 1.0mg
Intervention: ranibizumab
Outcomes
Primary Outcomes
BCVA
Time Frame: Baseline to M24
Mean change in best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters from Baseline to Month 24
Secondary Outcomes
- BCVA(at Baseline, Day 14, Month 1, Month 3, Month 6, Month 9 , Month 12, Month 15, Month 18, Month 21 and Month 24)
- Fundus Clinical Findings(Baseline, Months 6, 12, 24)
- Ocular Adverse Events (AE)(Monthly)
- Macular Edema(Baseline, Day 14, Month 1-24)
- Systemic AEs(Monthly)
- PCV Anatomic Changes(Baseline, Months 6, 12, 24)