NCT00570193

Brief Summary

The goal of this pilot study is to validate the use of the combination of Lucentis (ranibizumab) and Visudyne (verteporfin) in the treatment of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) and to explore the use of a volumetric analysis of the CNV lesion to determine disease activity, response to therapy, and as a tool for determining the need for retreatment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2006

Longer than P75 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, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 6, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 10, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

July 10, 2012

Status Verified

July 1, 2012

Enrollment Period

4.5 years

First QC Date

December 6, 2007

Last Update Submit

July 6, 2012

Conditions

Choroidal NeovascularizationMacular Degeneration

Outcome Measures

Primary Outcomes (1)

  • Visual change

    18 months

Secondary Outcomes (1)

  • Frequency of treatment

    18 months

Study Arms (2)

I

EXPERIMENTAL

Combined treatment with verteporfin (Visudyne) and ranibizumab (Lucentis)

Drug: verteporfin (Visudyne)

II

EXPERIMENTAL

Treatment with ranibizumab (Lucentis)

Drug: ranibizumab (Lucentis)

Interventions

verteporfin (Visudyne)DRUG

Verteporfin (Visudyne) 6 mg/m2 at 300mW/cm2 given on week O and then at week 5, given as indicated per protocol; ranibizumab (Lucentis) 0.3 mg given at week 1

Also known as: Visudyne = verteporfin, Lucentis = ranibizumab
I
ranibizumab (Lucentis)DRUG

ranibizumab (Lucentis) 0.3 mg on weeks 1,5,9,13,17,21,25,29,33\&37 per study protocol

Also known as: Lucentis = ranibizumab
II

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All previously untreated CNV secondary to MD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Choroidal NeovascularizationMacular Degeneration

Interventions

VerteporfinRanibizumab

Condition Hierarchy (Ancestors)

Choroid DiseasesUveal DiseasesEye DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and SymptomsRetinal DegenerationRetinal Diseases

Intervention Hierarchy (Ancestors)

PorphyrinsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic CompoundsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Nabil M Jabbour, MD

    Mid-Atlantic Retina Consultations

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2007

First Posted

December 10, 2007

Study Start

December 1, 2006

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

July 10, 2012

Record last verified: 2012-07