Trial | NCT00424710  Report issue

Title

Ranibizumab for Polypoidal Choroidal Vasculopathy (PCV)
Phase I Study of Ranibizumab Injection for Polypoidal Choroidal Vasculopathy (PEARL)

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ranibizumab ...

  • Study Participants

    17
This is a 12 month study of monthly injections of ranibizumab in subjects with polypoidal choroidal vasculopathy as diagnosed by fluoresceins/indocyanine green (FA/ICG) angiography.
Previous treatment in subjects is allowed as long as appropriate washout period has elapsed. Patients will be followed by 4M ETDRS vision testing as well as scheduled OCT, ICG, FA and Fundus Photography.
Study Started
Jan 31
2007
Primary Completion
Sep 30
2010
Study Completion
Sep 30
2010
Last Update
Nov 05
2014
Estimate

Drug ranibizumab intravitreal injection

liquid, 0.5 mg ranibizumab intravitreally, once a month for 1 year

Single Arm study Other

Single arm study: Drug: ranibizumab intravitreal injection liquid, 0.5 mg ranibizumab intravitreally, once a month for 1 year

Criteria 

Inclusion Criteria:

Ability to provide informed consent and comply with study assessment for the duration of one year
Age >= 25 years
Polypoidal Choroidal Vasculopathy as noted on fluorescein and ICG angiography: active leakage, active bleeding or recent decrease in vision
BCVA using ETDRS 20/32 to 20/400

Exclusion Criteria:

Any history of previous vitrectomy
Previous cataract or ocular surgery within 2 months of day 0
Active intraocular inflammation in the study eye
Active infections conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
Participation with another investigational drug within the past 30 days
Prior sodium pegaptanib, verteporfin photodynamic therapy, intravitreal steroids, or bevacizumab within 30 days of study entry
Blood pressure >180/110 (use of antihypertensives is allowed as long as hypertension can be controlled and is stable)
Pregnancy
No Results Posted