Clinical trial NCT01248117: Safety Study of High-Dose Ranibizumab for Polypoidal Choroidal Vasculopathy
Official title: Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab (2.0mg) Prospectively
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Polypoidal Choroidal Vasculopathy
Keywords: PCV
polypoidal
choroidal
vasculopathy
Lead sponsor: Retina Consultants of Hawaii
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2010-11-25
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* major surgery within 28 days prior to randomization
* Myocardial infarction, other cardia events requiring hospitalization within 6 months prior to randomization
* Systemic anti-VEGF or pro-VEGF within 3 months of randomization
* Pregnancy or lactation
* History of recurrent significant infections or bacterial infections

Primary outcomes:
measure: To evaluate the efficacy of intravitreal injections of 2.0mg ranibizumab administered monthly in preventing vision loss
timeFrame: 1 year
Secondary outcomes:
measure: To evaluate the safety and tolerability of intravitreal injections of 2.0mg ranibizumab administered monthly
timeFrame: 1 year
measure: To evaluate the efficacy of monthly intravitreal injections of 2.0mg ranibizumab in preventing vision loss
timeFrame: 1 year
measure: To investigate the efficacy of monthly intravitreal injections of 2.0mg ranibizumab on clinical findings associated with PCV
timeFrame: 1 year
Other outcomes:
Locations:
city: Aiea
country: United States
facility: Retina Consultants of Hawaii
state: Hawaii
city: Honolulu
country: United States
facility: Retina Consultants of Hawaii, Inc
state: Hawaii
Study officials:
affiliation: Retina Consultants of Hawaii
name: Gregg T Kokame, MD, MMM
role: PRINCIPAL_INVESTIGATOR
References: