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Photodynamic Therapy in Occult-Only Lesions (POOL)

This study has been completed.
Sponsor:
Collaborator:
QLT Inc.
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00135837
First received: August 24, 2005
Last updated: June 20, 2006
Last verified: June 2006
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:

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

ClinicalTrials.gov Identifier: NCT00135837     History of Changes
Other Study ID Numbers: CBPD952B2401
Study First Received: August 24, 2005
Last Updated: June 20, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Federal Ministry for Health and Women
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
 Uveal Diseases
Verteporfin
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013