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CompletedNCT00135837Updated Jun 21, 2006

Photodynamic Therapy in Occult-Only Lesions (POOL)

A Phase 4 interventional study of Verteporfin for injection in Age-Related Macular Degeneration, sponsored by Novartis. Completed at 1 site in Switzerland. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2006-06-21.

Sponsored by Novartis · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
202
Allocation
Non-randomized
Ages
50 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Age-Related Macular Degeneration

Keywords

  • Age related Macula Degeneration,
  • AMD,
  • choroidal neovascularisation (CNV),
  • occult CNV lesion,
  • verteporfin for injection,
  • photodynamic therapy (PDT)
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 202 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
202 participants

Interventions

  • DrugVerteporfin for injection
06

What researchers measure

Primary outcomes

  1. visual acuity measurements, baseline, 12 months

Secondary outcomes

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

07

Study locations

1 site
  • Novartis
    Basel, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00135837
Lead sponsor
Novartis
Collaborators
QLT Inc.
First posted
Aug 26, 2005
Start date
Jun 2003
Last update
Jun 21, 2006

Study contacts

Novartis Customer Information
study chair · Novartis
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2006. You cannot join it, but the record below documents what was studied.

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