Recruiting
Phase 1
Phase 2

Ranibizumab

Sponsor:

Retina Consultants of Hawaii

Code:

NCT01248117

Conditions

Polypoidal Choroidal Vasculopathy

Eligibility Criteria

Sex: All

Age: 25+

Healthy Volunteers: Accepted

Interventions

ranibizumab 2.0mg

Study Details

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

Study ID

NCT01248117

Start date

Nov, 2010

Status verified date

Nov, 2010

Completion date

Feb, 2013

Anticipated

Primary completion date

Dec, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25+

Healthy Volunteers: Accepted

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

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Previously Treated

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

experimental: Treatment-Naive

Treatment-Naive: no previous treatment for PCV

Interventions

ranibizumab 2.0mg

Monthly, intravitreal injection 0.05ml

Primary outcome measure

  • To evaluate the efficacy of intravitreal injections of 2.0mg ranibizumab administered monthly in preventing vision loss [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Jacqueline F Shen

(808) 380-8060jshen@retinahi.com

Locations

Retina Consultants of Hawaii

Recruiting

Aiea, Hawaii, United States, 96701

Contacts

Jacqueline F Shen

808-380-8060jshen@retinahi.com

Principal Investigator:

Gregg T Kokame, MD, MMM

Retina Consultants of Hawaii, Inc

Recruiting

Honolulu, Hawaii, United States, 96819

Contacts

Jacqueline F Shen

808-380-8060jshen@retinahi.com

Principal Investigator:

Gregg T Kokame, MD, MMM

More Information

Sponsor

Retina Consultants of Hawaii

Last update posted

Nov 25, 2010

Last verified

Nov, 2010

Keywords

  • PCV
  • polypoidal
  • choroidal
  • vasculopathy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Retina Consultants of Hawaii on 2010-11-25.