Safety Study of High-Dose Ranibizumab for Polypoidal Choroidal Vasculopathy

NCT01248117 | Unknown Phase 1

• 1 other identifier: FVF4929s
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Polypoidal Choroidal Vasculopathy

Keywords

PCV; polypoidal; choroidal; vasculopathy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Study Arms (2)

Previously Treated

EXPERIMENTAL

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

Drug: ranibizumab 2.0mg

Treatment-Naive

EXPERIMENTAL

Treatment-Naive: no previous treatment for PCV

Drug: ranibizumab 2.0mg

Interventions

ranibizumab 2.0mg DRUG

Monthly, intravitreal injection 0.05ml

Previously Treated; Treatment-Naive

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Retina Consultants of Hawaii: lead
• Genentech, Inc.: collaborator

Study Sites (2)

Retina Consultants of Hawaii, Inc

Honolulu, Hawaii, 96819, United States

RECRUITING

Retina Consultants of Hawaii

‘Aiea, Hawaii, 96701, United States

RECRUITING

MeSH Terms

Conditions

Polypoidal Choroidal Vasculopathy; Vascular Diseases

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Choroidal Neovascularization; Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Gregg T Kokame, MD, MMM

  Retina Consultants of Hawaii

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacqueline F Shen

CONTACT

(808) 380-8060; jshen@retinahi.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 24, 2010
• First Posted: November 25, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: February 1, 2013
• Last Updated: November 25, 2010

Record last verified: 2010-11

Locations

US (2)