Status:
COMPLETED
Comparison of Safety, Effectiveness and Quality of Life Outcomes Between Labeled Versus "Treat and Extend" Regimen in Turkish Patients With Choroidal Neovascularisation Due to Age-related Macular Degeneration (AMD)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
The purpose of the study was to compare 2 treatment regimens for patients suffering from choroidal neovascularisation secondary to age-related macular degeneration (AMD). The first treatment regimen w...
Eligibility Criteria
Inclusion
- Male or female patients over the age of 50.
- Patients with primary, secondary, or recurrent subfoveal choroidal neovascularization (CNV) to AMD with classic, minimal classic, or occult lesions.
- Patients with CNV area ≥ %50 of the total lesion.
- Total lesion area ≤ 12 disc areas for minimal classic/occult lesions and ≤ 9 disc areas for the classic lesions.
- Best-corrected visual acuity (BCVA) score between 73 and 34 letters in the study eye.
Exclusion
- BCVA \< 34 letters.
- Patients using anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, corticosteroids, or protein kinase C inhibitors, etc) or inclusion in another trial (for any eye).
- Verteporphin, external radiational therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy application to the eye before the study.
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT01148511
Start Date
February 1 2010
End Date
April 1 2012
Last Update
May 30 2013
Active Locations (8)
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1
Novartis Investigative Site
Adana, Turkey (Türkiye)
2
Novartis Investigational Site
Ankara, Turkey (Türkiye)
3
Novartis Investigative Site
Ankara, Turkey (Türkiye)
4
Novartis Investigative Site
Bursa, Turkey (Türkiye)