Photodynamic Therapy in Occult-Only Lesions (POOL) | NCT00135837

Studies
Photodynamic Therapy in Occult-Only Lesions (POOL)

NCT00135837

Sponsor

Novartis

Status

Completed

Last Update Posted

Jun 21, 2006Estimated

Enrollment

202

Phase

Phase 4

Conditions

Age-Related Macular Degeneration

Interventions

Verteporfin for injection

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2003

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Aug 24, 2005

First Submission Date that Met QC Criteria

Aug 24, 2005

First Posted Date

Aug 26, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2006

Last Update Posted Date

Jun 21, 2006Estimated

Name	Class
QLT Inc.	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

202

Name	Type	Description	Arm Group Labels	Other Names
Verteporfin for injection	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
visual acuity measurements, baseline, 12 months

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Novartis Customer Information	Novartis	Study Chair

Condition Browse Module

MeSH Terms

ID	Term
D008268	Macular Degeneration
D020256	Choroidal Neovascularization

Ancestor Terms

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases
D015862	Choroid Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077362	Verteporfin
D007267	Injections

Ancestor Terms

ID	Term
D011166	Porphyrins
D045725	Tetrapyrroles
D011758	Pyrroles
D001393	Azoles
D006573

Browse Leaves

Not provided

Browse Branches

Not provided