Clinical trial NCT01148511: 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)
Official title: Comparison of Safety, Effectiveness, and Quality-of-life Outcomes Between Labeled Versus "Treat and Extend" Regimen in Turkish Patients With Choroidal Neovascularisation Due to AMD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Age-related Macular Degeneration
Keywords: Macula degeneration
Ranibizumab
Choroidal neovascularisation
Treat and extend
Treat and observe
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-06-22
Enrollment: 99
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 was the approved AMD treatment of 1 injection each month for 3 months and than re-treatment of patients who have a visual loss of more than 5 letters with monthly control (Treat and Observe). The second treatment regimen was 1 injection each month for 3 months and than extending the control period if the macula is dry during the monthly control (Treat and Extend). If the "Treat and Extend" regimen is found effective and safe, the number of ranibizumab injections, the number of patient visits, the risk of adverse events due to the intravitreal injections, and policlinic occupation number could all be reduced.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Change in Best-Corrected Visual Acuity (logMAR) From Baseline to Month 12
timeFrame: Baseline to Month 12
measure: Change in Letter Count From Baseline to Month 12
timeFrame: Baseline to Month 12
Secondary outcomes:
measure: Letter Count From Baseline to Month 12
timeFrame: Baseline to Month 12
measure: Number of Visits
timeFrame: Baseline to Month 12
measure: Follow-up Duration
timeFrame: Baseline to Month 12
measure: Change in Central Retinal Thickness From Baseline to Month 12
timeFrame: Baseline to Month 12
measure: Quality of Life
timeFrame: Visits 2, 6, 9, 12, and 15 (up to 12 months)
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigational Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Bursa
country: Turkey
facility: Novartis Investigative Site
city: Eskişehir
country: Turkey
facility: Novartis Investigative Site
city: İstanbul
country: Turkey
facility: Novartis Investigative Site
city: İzmir
country: Turkey
facility: Novartis Investigative Site
city: Konya
country: Turkey
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: