Visual Impairment Due to Choroidal Neovascularization (CNV) Secondary to Pathologic Myopia (PM) Clinical Trial
Official title:
A 12-month, Phase III, Randomized, Double-masked, Multicenter, Active-controlled Study to Evaluate the Efficacy and Safety of Two Individualized Regimens of 0.5mg Ranibizumab vs. Verteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia
This study was designed to evaluate the efficacy and safety of two different dosing regimens of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in patients with visual impairment due to choroidal neovascularization secondary to pathologic myopia (PM)
This was a phase III, multi-center, randomized, double-masked, active-controlled study
comparing 0.5 mg ranibizumab vs. vPDT therapy. The study included 15 scheduled visits over 12
months, and there were to be two additional visits (2a, 3a) for subset of patients in whom PK
analysis were performed.
There were 3 periods in this study: Screening period-from Day -14 to Baseline; Treatment
period-from Baseline to Month 11; Follow-up period-from Month 11 to Month 12 Patients entered
the 11 months Treatment period at Visit 2 (Day 1) if eligibility criteria were met and were
randomized in three treatment groups Group I ranibizumab 0.5 mg driven by VA stability
criteria or Group II ranibizumab 0.5 mg driven by disease activity criteria or Group III vPDT
(randomization ratio of 2:2:1) and received first treatment of either a ranibizumab injection
and sham vPDT or sham injection and active vPDT and will return to the clinical center within
7 days to undergo safety assessments as well as assessments of the effect of treatment by the
evaluating investigator. The following visits were performed at one month intervals starting
at Visit 4 and continuing through Visit 14. At all monthly visits (at/from Month 2 for group
I, at/from Month 1 for group II and at/from Month 3 for group III) the decision for treatment
were made by the evaluating investigator based on the VA stability criteria and on the
disease activity criteria. At Month 3 (visit 6) and at all following monthly visits for all
three groups one of the three options can recommended by evaluating investigator: a)
ranibizumab 0.5 mg, b) ranibizumab 0.5 mg + vPDT; c) vPDT. The treating investigator were
then perform treatment based on randomization and masking requirements.
At each monthly visit, patients had a safety evaluation by the evaluating investigator prior
to study treatment, consisting of visual acuity measurements, ophthalmic examinations and
evaluation of adverse events and vital signs. Routine hematology, chemistry, and urinalysis
profiles were obtained at Visit 6, 9 and 12 (Month 3, 6 and 9). At Month 12 several
procedures and assessments were performed which are required at study completion visit.
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