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Efficacy and Safety of Ranibi...

Efficacy and Safety of Ranibizumab 0.5 vs Verteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia

NCT ID: NCT01922102

Last Updated: 2019-06-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

457 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-11

Study Completion Date

2016-09-14

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Visual Impairment Due to Choroidal Neovascularization (CNV) Secondary to Pathologic Myopia (PM)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group I

0.5 mg ranibizumab driven by visual acuity stability criteria

Group Type EXPERIMENTAL

Ranibizumab 0.5mg

Intervention Type DRUG

0.5 mg ranibizumab (intravitreal injections)

Group II

0.5 mg ranibizumab driven by disease activity criteria

Group Type EXPERIMENTAL

Ranibizumab 0.5 mg

Intervention Type DRUG

0.5 mg ranibizumab (intravitreal injections)

Group III

verteporfin PDT

Group Type ACTIVE_COMPARATOR

Verteporfin PDT

Intervention Type DRUG

Verteporfin for intravenous injection delivered by intravenous infusion followed by the light application

Interventions

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Ranibizumab 0.5mg

0.5 mg ranibizumab (intravitreal injections)

Intervention Type DRUG

Ranibizumab 0.5 mg

0.5 mg ranibizumab (intravitreal injections)

Intervention Type DRUG

Verteporfin PDT

Verteporfin for intravenous injection delivered by intravenous infusion followed by the light application

Intervention Type DRUG

Other Intervention Names

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Lucentis Lucentis Visudyne

Eligibility Criteria

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Inclusion Criteria

* Visual impairment due to CNV secondary to PM.
* Best corrected visual acuity in the study eye \> 24 and \< 78 ETDRS letters.
* High myopia (\> -6D),
* anterio-posterior elongation \> 26 mm; posterior changes compatible with the pathologic myopia.
* Either CNV locations in the study eye: subfoveal, juxtafoveal, extrafoveal.

Exclusion Criteria

* Some preexisting eye disorders or systemic diseases;-Blood pressure \> 150/90 mmHg
* Prior focal/grid laser to the macular area -History of treatment with any anti-VEGF or verteporfin PDT in the study eye
* Intravitreal treatment with corticosteroids or intraocular surgery within last 3 months in the study eye

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers