NCT00395551

Brief Summary

The purpose of this study is to determine whether ranibizumab is effective in the treatment of choroidal neovascularization secondary to causes other then wet macular-degeneration.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2005

Typical duration for phase_1

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

December 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

January 8, 2010

Status Verified

January 1, 2010

Enrollment Period

3.5 years

First QC Date

November 1, 2006

Last Update Submit

January 7, 2010

Conditions

Choroidal Neovascularization

Keywords

choroidal neovascularizationChoroidal Neovascularization Not related to Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measures for safety and tolerability

    Mean change in visual acuity from baseline to 6 months & 12 months

Secondary Outcomes (1)

  • The secondary outcome measures for efficacy

    Mean change in visual acuity from baseline to 6 & 12 months. Change in retinal thickness from baseline to week 1, month 1, 2, 3, 6, & 12 measured by OCT. Change in area of CNV from baseline to month 3, 6 & 12 measured by FA

Study Arms (1)

ranibizumab

ACTIVE COMPARATOR

ranibizumab 0.5mg intravitreal injection

Drug: ranibizumab

Interventions

ranibizumabDRUG

0.5mg intravitreal injection

ranibizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • active choroidal neovascularization

You may not qualify if:

  • pregnancy,age-related macular degeneration, current eye infection or recent eye surgery, participating in other eye studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Choroidal 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

  • Jeffrey S Heier, M.D.

    Ophthalmic Consultants of Boston

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 1, 2006

First Posted

November 3, 2006

Study Start

December 1, 2005

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

January 8, 2010

Record last verified: 2010-01