Photodynamic Therapy in Occult-Only Lesions (POOL) - Full Text View

Sponsor:	Novartis
Collaborator:	QLT Inc
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00135837

Purpose

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.

Condition	Intervention	Phase
Age-Related Macular Degeneration	Drug: Verteporfin for injection	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Verteporfin

U.S. FDA Resources

Further study details as provided by Novartis:

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

Estimated Enrollment:	202
Study Start Date:	June 2003

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135837

Locations

Switzerland
Novartis
Basel, Switzerland

Sponsors and Collaborators

Novartis

QLT Inc

Investigators

Study Chair:

Novartis Customer Information

Novartis

More Information

No publications provided

Study ID Numbers:	CBPD952B2401
Study First Received:	August 24, 2005
Last Updated:	June 20, 2006
ClinicalTrials.gov Identifier:	NCT00135837 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Austria: Federal Ministry for Health and Women; France: Afssaps - French Health Products Safety Agency; Italy: Ministry of Health; Spain: Ministry of Health and Consumption; Portugal: National Pharmacy and Medicines Institute; Poland: Ministry of Health; United Kingdom: National Health Service; Finland: Finnish Medicines Agency; Denmark: National Board of Health; Sweden: Medical Products Agency

Keywords provided by Novartis:

Age related Macula Degeneration,
AMD,
choroidal neovascularisation (CNV),

occult CNV lesion,
verteporfin for injection,
photodynamic therapy (PDT)

Additional relevant MeSH terms:

Uveal Diseases
Eye Diseases
Physiological Effects of Drugs
Choroid Diseases
Verteporfin
Macular Degeneration
Retinal Degeneration
Pharmacologic Actions
Choroidal Neovascularization

Photosensitizing Agents
Pathologic Processes
Radiation-Sensitizing Agents
Therapeutic Uses
Metaplasia
Neovascularization, Pathologic
Dermatologic Agents
Retinal Diseases

ClinicalTrials.gov processed this record on November 27, 2009