NCT00455871

Brief Summary

The purpose of this study is to determine the benefits, if any, of combination therapy with Lucentis plus reduced fluence photodynamic therapy with Visudyne.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2007

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

May 9, 2008

Status Verified

May 1, 2008

Enrollment Period

3.5 years

First QC Date

April 2, 2007

Last Update Submit

May 6, 2008

Conditions

Age-Related Macular Degeneration

Keywords

macular degeneration

Outcome Measures

Primary Outcomes (2)

  • To assess the safety of the combination therapy

    12 months and 24 months

  • To assess efficacy of the two timing regimens

    12 months and 24 months

Secondary Outcomes (1)

  • To evaluate the number of Lucentis injections and the number of PDT treatments required during the study

    12 months and 24 months

Study Arms (2)

Lucentis plus Reduced Fluence PDT same day

ACTIVE COMPARATOR
Drug: reduced fluence photodynamic therapy with VisudyneDrug: Lucentis

Lucentis plus reduced fluence PDT 1-2 weeks later

ACTIVE COMPARATOR
Drug: reduced fluence photodynamic therapy with VisudyneDrug: Lucentis

Interventions

reduced fluence photodynamic therapy with VisudyneDRUG

reduced fluence photodynamic therapy with visudyne

Lucentis plus Reduced Fluence PDT same dayLucentis plus reduced fluence PDT 1-2 weeks later
LucentisDRUG

Lucentis intravitreal injection

Lucentis plus Reduced Fluence PDT same dayLucentis plus reduced fluence PDT 1-2 weeks later

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to give informed consent
  • Treatment- naïve patients with active, subfoveal, exudative AMD
  • Patients with visual acuity of 20/40-20/320 in the study eye
  • Subfoveal choroidal neovascularization (CNV) must be at least 50% of the total lesion size Total area of lesion components other that CNV must be less than 50% of the total lesion size
  • The lesion must be \< 5400microns in greatest linear dimension (GLD)
  • Lesion size \< 10 DA
  • Occult with no classic CNV lesions must have presumed recent disease progression:
  • Blood associated with the lesion at baseline
  • Loss of visual acuity in the previous 3 months: a: \> 5 letter loss (ETDRS equivalent) or b: 2 or more lines using a snellen or equivalent chart
  • \> 10% increase in GLD as assessed by fluorescein angiography in the previous 3 months
  • Previous treatment for CNV with anti-VEGF agents, intraocular steroids and/or Photodynamic therapy with Visudyne® in the study eye
  • Geographic atrophy or fibrosis in the study eye
  • Intraocular surgery within 6 weeks of enrollment
  • Subretinal hemorrhage \> 50% of the total lesion
  • Patients with intraocular pressure greater than 30 mm/Hg on 2 pressure-lowering medications
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barnes Retina Institute

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Interventions

VerteporfinRanibizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye 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

  • Gaurav K. Shah, MD

    Barnes Retina Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamela A Light, CCRC

CONTACT

314-367-1278bristudies@barnesretinainstitute.com

Rhonda F Weeks

CONTACT

314-367-1278bristudies@barnesretinainstitute.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 2, 2007

First Posted

April 4, 2007

Study Start

April 1, 2007

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

May 9, 2008

Record last verified: 2008-05

Locations

US(1)