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Photodynamic Therapy in Occult-Only Lesions (POOL)

Primary Purpose

Age-Related Macular Degeneration

Status

Completed

Phase

Phase 4

Locations

Switzerland

Study Type

Interventional

Intervention

Verteporfin for injection

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration focused on measuring Age related Macula Degeneration,, AMD,, choroidal neovascularisation (CNV),, occult CNV lesion,, verteporfin for injection,, photodynamic therapy (PDT)

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 50 years or older Must see better or equal to 34 letters (visual acuity) Choroidal neovascularization (CNV) lesion must be occult only Exclusion Criteria: Evidence of classic CNV in the lesion Prior treatment of disease in study eye Have a history of moderate to severe hepatic impairment Other protocol-defined exclusion criteria may apply.

Sites / Locations

Novartis

Outcomes

Primary Outcome Measures

visual acuity measurements, baseline, 12 months

Secondary Outcome Measures

visual acuity measurements, fundus photographs and fluorescein angiography at baseline, 12 months; ophthalmic examinations, adverse events, vital signs, concomitant medications, 12 months

Full Information

NCT ID

NCT00135837

First Posted

August 24, 2005

Last Updated

June 20, 2006

Sponsor

Novartis

Collaborators

QLT Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00135837

Brief Title

Photodynamic Therapy in Occult-Only Lesions (POOL)

Official Title

An Open-Label, Multicenter, Phase 4 Study of the Effect of Verteporfin for Injection Therapy in Subjects With Occult With No Classic Choroidal NeoVascularization Secondary to Age-Related Macular Degeneration

Study Type

Interventional

2. Study Status

Record Verification Date

June 2006

Overall Recruitment Status

Completed

Study Start Date

June 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Novartis

Collaborators

QLT Inc.

4. Oversight

5. Study Description

Brief Summary

Age related macular degeneration is the leading cause of blindness for people over 50 in the western world. Blood vessels which start to grow form a lesion in the back of the eye. Verteporfin may stabilize the disease, by closing the blood vessels. This study will assess the efficacy and safety of verteporfin in patients with occult only lesions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Age-Related Macular Degeneration

Keywords

Age related Macula Degeneration,, AMD,, choroidal neovascularisation (CNV),, occult CNV lesion,, verteporfin for injection,, photodynamic therapy (PDT)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

202 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Verteporfin for injection

Primary Outcome Measure Information:

Title

visual acuity measurements, baseline, 12 months

Secondary Outcome Measure Information:

Title

visual acuity measurements, fundus photographs and fluorescein angiography at baseline, 12 months; ophthalmic examinations, adverse events, vital signs, concomitant medications, 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Customer Information

Organizational Affiliation

Novartis

Official's Role

Study Chair

Facility Information:

Facility Name

Novartis

City

Basel

Country

Switzerland

12. IPD Sharing Statement

Learn more about this trial

Photodynamic Therapy in Occult-Only Lesions (POOL)

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