Safety Study of High-Dose Ranibizumab for Polypoidal Choroidal Vasculopathy (PEARL2)

Retina Consultants of Hawaii

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Polypoidal Choroidal Vasculopathy

Treatments: Drug: ranibizumab 2.0mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01248117

FVF4929s

Details and patient eligibility

About

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.

Full description

Patients will be followed with spectral oct, 4m BCVA, ICG, FA and monthly eye examinations for one year.

Enrollment: 20 estimated patients

Sex: All

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Previously Treated

Experimental group

Description:

With prior anti-vegf therapy, only, no sooner than 30 days prior to enrollment into trial

Treatment:

Drug: ranibizumab 2.0mg

Treatment-Naive

Experimental group

Description:

Treatment-Naive: no previous treatment for PCV

Treatment:

Drug: ranibizumab 2.0mg