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Completed

NCT Number: NCT00424710

Ranibizumab for Polypoidal Choroidal Vasculopathy (PCV)

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.

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Key information

Conditions

Polypoidal Choroidal Vasculopathy Choroid Diseases Choroidal Neovascularization Eye Diseases Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Uveal Diseases

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Retina Consultants of Hawaii, Honolulu, Hawaii, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ranibizumab intravitreal injection

Drug

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

Primary outcomes

  1. Efficacy Measured by the proportion of subjects who lose fewer than 15 letters in visual acuity at 6 and 12 month compared with baseline

    Time frame: 1 year

  2. Safety and Tolerability as measured by the recording and observations of adverse effects of study treatment

    Time frame: 1 Year

Secondary outcomes

  1. Efficacy as measured by the mean change from baseline in VA at 6 and 12 months

    Time frame: 1 Year

  2. Efficacy as measured by the proportion of subjects who lose less than 5 letters of vision at month 6 and 12

    Time frame: 1 Year

  3. Efficacy as mean change from baseline at 6 to 12 months in decreasing subretinal hemorrhage or subretinal exudates via fundus photographs and fundus exams

    Time frame: 1 Year

  4. Efficacy as proportion of subjects with a decrease in size of the polypoidal vessels from PCV at Mo 6 and 12 as assessed by FA and ICG Angiography

    Time frame: 1 Year

  5. Efficacy as proportion of subjects with a decrease in macular edema as measured by OCT in central or paracentral fields from baseline month 6 and month 12.

    Time frame: 1 Year

Sponsors and collaborators

Lead sponsor

Hawaii Pacific Health

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

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

Acronym: PEARL

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jan 19, 2007
Registry last updated
Nov 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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