NCT00135837

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2005

Completed
Last Updated

June 21, 2006

Status Verified

June 1, 2006

First QC Date

August 24, 2005

Last Update Submit

June 20, 2006

Conditions

Age-Related Macular Degeneration

Keywords

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

Outcome Measures

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

Interventions

Verteporfin for injectionDRUG

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Must see better or equal to 34 letters (visual acuity)
  • Choroidal neovascularization (CNV) lesion must be occult only

You may not qualify if:

  • Evidence of classic CNV in the lesion
  • Prior treatment of disease in study eye
  • Have a history of moderate to severe hepatic impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

Basel, Switzerland

Location

MeSH Terms

Conditions

Macular DegenerationChoroidal Neovascularization

Interventions

VerteporfinInjections

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesChoroid DiseasesUveal DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PorphyrinsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic CompoundsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Novartis Customer Information

    Novartis

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 24, 2005

First Posted

August 26, 2005

Study Start

June 1, 2003

Last Updated

June 21, 2006

Record last verified: 2006-06

Locations

CH(1)