Phase 3 N=457 Randomized Triple-blind Treatment

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

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

Bottom Line

View on ClinicalTrials.gov: NCT01922102 ↗

Enrolled (actual)

457

Serious AEs

6.6%

Results posted

Jun 2019

Primary outcome: Primary: Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 3 — 53.7; 54.2; 52.6; 63.1 ETDRS letters — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ranibizumab 0.5mg (Drug); Ranibizumab 0.5 mg (Drug); Verteporfin PDT (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Sep 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 3	53.7; 54.2; 52.6; 63.1; 63.9; 57.1	<0.001 sig
SECONDARY Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 6	53.7; 54.2; 52.6; 64.1; 64.9; 59.6	<0.001 sig
SECONDARY The Average Change in BCVA Score From Baseline to Month 1 Through Month 12	53.7; 54.2; 52.6; 64.8; 65.9; 61.2	—
SECONDARY Mean Change From Baseline in Visual Acuity Over Time	10.5; 10.8; 4.5; 11.6; 12.1; 9.5	—
SECONDARY Categorized BCVA Changes at Months 3, 6 and 12 Compared With Baseline for the Study Eye	58; 59; 15; 97; 107; 24	—
SECONDARY Mean Change From Baseline Over Time in Central Sub-field Thickness (CSFT)	-66.4; -71.2; -29.1; -70.7; -75.1; -59.3	—
SECONDARY Number of Patients With CNV Leakage (Center Involvement) in the Study Eye at Baseline and Month 12	164; 160; 76; 1; 3; 0	—
SECONDARY NEI-VFQ-25 - Change From Baseline to Month 3, 6 and 12	4.7; 6.1; 1.7; 5.0; 5.6; -0.1	—
SECONDARY Number of Ranibizumab Injections Received in the Study Eye for the Ranibizumab Groups	2.4; 2.1; NA; NA; 4.6; 3.9	—

Summary

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)

Eligibility Criteria

Inclusion Criteria

Visual impairment due to CNV secondary to PM.
Best corrected visual acuity in the study eye > 24 and -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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01922102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.