Recruiting

Lucentis & Visudyne

Sponsor:

Barnes Retina Institute

Code:

NCT00455871

Conditions

Age-Related Macular Degeneration

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

reduced fluence photodynamic therapy with Visudyne

Lucentis

Study Details

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.

Conditions

Age-Related Macular Degeneration

Study ID

NCT00455871

Start date

Apr, 2007

Status verified date

May, 2008

Completion date

Oct, 2010

Anticipated

Primary completion date

Oct, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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:

1. Blood associated with the lesion at baseline
2. 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
3. > 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
  • Patients with severe disciform scarring.
  • Inability to make study visits
  • Advanced glaucoma
  • Allergies to porfins or a known hypersensitivity to any component of Visudyne®
  • Patients with porphyria
  • Pregnancy or lactation

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Lucentis plus Reduced Fluence PDT same day

active comparator: Lucentis plus reduced fluence PDT 1-2 weeks later

Interventions

reduced fluence photodynamic therapy with Visudyne

reduced fluence photodynamic therapy with visudyne

Lucentis

Lucentis intravitreal injection

Primary outcome measure

  • To assess the safety of the combination therapy [ Time Frame: 12 months and 24 months ]
  • To assess efficacy of the two timing regimens [ Time Frame: 12 months and 24 months ]

Central Contacts and Locations

Locations

Barnes Retina Institute

Recruiting

St. Louis, Missouri, United States, 63110

Principal Investigator:

Gaurav K Shah, MD

More Information

Sponsor

Barnes Retina Institute

Last update posted

May 9, 2008

Last verified

May, 2008

Keywords

  • macular degeneration

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Barnes Retina Institute on 2008-05-09.