Safety Study of High-Dose Ranibizumab for Polypoidal Choroidal Vasculopathy

Polypoidal Choroidal Vasculopathy Clinical Trial

— PEARL2  

Official title:

Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab (2.0mg) Prospectively

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01248117
• Other study ID #: FVF4929s
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: November 24, 2010
• Last updated: November 24, 2010
• Start date: November 2010
• Est. completion date: February 2013

Study information

• Verified date: November 2010
• Source: Retina Consultants of Hawaii
• Contact: Jacqueline F Shen
• Phone: (808) 380-8060
• Email: jshen[@]retinahi.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polypoidal Choroidal Vasculopathy
• Vascular Diseases

Intervention

Drug:
• ranibizumab 2.0mg
Monthly, intravitreal injection 0.05ml

Locations

Country	Name	City	State
United States	Retina Consultants of Hawaii	Aiea	Hawaii
United States	Retina Consultants of Hawaii, Inc	Honolulu	Hawaii

Sponsors (2)

Lead Sponsor	Collaborator
Retina Consultants of Hawaii	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy of intravitreal injections of 2.0mg ranibizumab administered monthly in preventing vision loss	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	1 year	No
Secondary	To evaluate the safety and tolerability of intravitreal injections of 2.0mg ranibizumab administered monthly	To evaluate the safety and tolerability of intravitreal injections of 2.0mg ranibizumab administered monthly	1 year	Yes
Secondary	To evaluate the efficacy of monthly intravitreal injections of 2.0mg ranibizumab in preventing vision loss	To evaluate the efficacy of monthly intravitreal injections of 2.0mg ranibizumab in preventing vision loss as measured by the following: mean change from baseline in VA at 6 and 12 months, and the proportion of subjects who lose less than 5 letters of vision at Month 6 and Month 12.	1 year	No
Secondary	To investigate the efficacy of monthly intravitreal injections of 2.0mg ranibizumab on clinical findings associated with PCV	the mean change from baseline at M6 to M12 of subretinal hemorrhage and/or exudates via fundus photographs and fundus exams, decrease and/or complete resolution of branching vascular network from PCV at M3, M6, and M12 as assessed by FA and ICG, decrease and/or complete resolution of the branching vascular network (BVN) from PCV at M3, M6, and M12, as assessed by FA and ICG, mean change in central foveal thickness and/or peripapillary edema as measured by SD-OCT in central and/or paracentral fields from baseline, M3, M6 and M12, incidence of ocular AEs	1 year	Yes