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Study of Treatment Effects of Combination Therapy of Lucentis Plus Reduced Fluence PDT With Visudyne in Patients With Exudative AMD

NCT ID: NCT00455871

Last Updated: 2008-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2010-10-31

Brief Summary

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

Detailed Description

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The study will have two treatment groups. Each group will receive intravitreal injections (injection of medication in the jelly-like part of the back of the eye). One group (Group1) of approximately 15 patients will receive 0.5 mg of Lucentis™ followed by reduced fluence Photodynamic Therapy (PDT) with Visudyne ® 1-2 weeks later. The other group (Group 2) of approximately 15 patients will receive 0.5 mg of Lucentis™ followed by Photodynamic Therapy with Visudyne on the same day. patients will be assigned at random to receive one of the two treatments arms in the study. The dose received at the first injection will be the same dose received throughout the study.

Conditions

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Age-Related Macular Degeneration

Keywords

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macular degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lucentis plus Reduced Fluence PDT same day

Group Type ACTIVE_COMPARATOR

reduced fluence photodynamic therapy with Visudyne

Intervention Type DRUG

reduced fluence photodynamic therapy with visudyne

Lucentis

Intervention Type DRUG

Lucentis intravitreal injection

Lucentis plus reduced fluence PDT 1-2 weeks later

Group Type ACTIVE_COMPARATOR

reduced fluence photodynamic therapy with Visudyne

Intervention Type DRUG

reduced fluence photodynamic therapy with visudyne

Lucentis

Intervention Type DRUG

Lucentis intravitreal injection

Interventions

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reduced fluence photodynamic therapy with Visudyne

reduced fluence photodynamic therapy with visudyne

Intervention Type DRUG

Lucentis

Lucentis intravitreal injection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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QLT Inc.

INDUSTRY

Sponsor Role collaborator

Barnes Retina Institute

OTHER

Sponsor Role lead

Responsible Party

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Barnes Retina Institute

Principal Investigators

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Gaurav K. Shah, MD

Role: PRINCIPAL_INVESTIGATOR

Barnes Retina Institute

Locations

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Barnes Retina Institute

St Louis, Missouri, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Pamela A Light, CCRC

Role: CONTACT

Phone: 314-367-1278

Email: [email protected]

Rhonda F Weeks

Role: CONTACT

Phone: 314-367-1278

Email: [email protected]

Other Identifiers

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NCT00455871

Identifier Type: -

Identifier Source: secondary_id

06-0769

Identifier Type: -

Identifier Source: org_study_id