At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Ranibizumab 0.5 mg for Age-related Macular Degeneration. Completed, enrolled 99 participants across 8 sites.
Detailed 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.
Study Details
Timeline
Interventions
Ranibizumab was supplied as a sterile solution in sealed glass vials.