NCT00424710

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2007

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2007

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

November 5, 2014

Status Verified

November 1, 2014

Enrollment Period

3.7 years

First QC Date

January 18, 2007

Last Update Submit

November 3, 2014

Conditions

Polypoidal Choroidal Vasculopathy

Keywords

choroidal neovascularization

Outcome Measures

Primary Outcomes (2)

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

    1 year

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

    1 Year

Secondary Outcomes (5)

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

    1 Year

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

    1 Year

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

    1 Year

  • 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

    1 Year

  • 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.

    1 Year

Study Arms (1)

Single Arm study

OTHER

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

Drug: ranibizumab intravitreal injection

Interventions

ranibizumab intravitreal injectionDRUG

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

Single Arm study

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Retina Consultants of Hawaii

Honolulu, Hawaii, 96817, United States

Location

The Retina Center at Pali Momi

‘Aiea, Hawaii, 96701, United States

Location

Related Publications (1)

  • Kokame GT, Yeung L, Lai JC. Continuous anti-VEGF treatment with ranibizumab for polypoidal choroidal vasculopathy: 6-month results. Br J Ophthalmol. 2010 Mar;94(3):297-301. doi: 10.1136/bjo.2008.150029. Epub 2009 Sep 1.

    PMID: 19726427RESULT

MeSH Terms

Conditions

Polypoidal Choroidal VasculopathyChoroidal Neovascularization

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Choroid DiseasesUveal DiseasesEye DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Gregg T Kokame, MD

    The Retina Center at Pali Momi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director, The Retina Center at Pali Momi

Study Record Dates

First Submitted

January 18, 2007

First Posted

January 19, 2007

Study Start

January 1, 2007

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

November 5, 2014

Record last verified: 2014-11

Locations

US(2)