Phase 3 N=277 Randomized Triple-blind Treatment

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

Pathological Myopia

Bottom Line

View on ClinicalTrials.gov: NCT01217944 ↗

Enrolled (actual)

277

Serious AEs

4.7%

Results posted

Oct 2013

Primary outcome: Primary: Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye — 55.4; 55.8; 54.7; 66.0 Letters

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ranibizumab (Drug); Verteporfin PDT (Drug); Sham Ranibizumab (Drug); Sham verteporfin PDT (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Aug 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye	55.4; 55.8; 54.7; 66.0; 66.4; 56.9	—
SECONDARY Average Change From Baseline to Month 6 in Visual Acuity of the Study Eye	55.4; 55.8; 54.7; 69.2; 68.4; 62.7	—
SECONDARY Average Change From Baseline to Month 1 Through Month 12 in Visual Acuity of the Study Eye	55.4; 55.8; 54.7; 68.3; 68.3; 61.1	—
SECONDARY Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 3	38.1; 43.1; 14.5; 61.9; 65.5; 27.3	—
SECONDARY Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 6 and Month 12	46.7; 44.8; 71.4; 64.7; 53.3; 51.7	—
SECONDARY Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 3	1.9; 0.9; 16.4; 1.9; 0; 7.4	—
SECONDARY Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 6 and 12	1.9; 2.6; 0; 0.9; 4.8; 1.7	—
SECONDARY Change From Baseline in Central Retinal Thickness of the Study Eye Over Time	349.2; 373.1; 352.5; 288.3; 295.6; 340.5	—
SECONDARY Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye	96.2; 93.1; 100.0; 1.0; 0.0; 0.0	—
SECONDARY Number of Ranibizumab Injections Received Prior to Month 3	2.5; 1.8; 0.0	—
SECONDARY Number of Ranibizumab Injections Received by Patients Randomized to the Ranibizumab Groups, by Period	3.5; 2.5; 4.6; 3.5	—
SECONDARY Number of Ranibizumab Injections Received by Patients Randomized to vPDT With Ranibizumab From Month 3 by Period	1.9; 3.2	—

Summary

This study is 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 (CNV) secondary to pathologic myopia (PM).

Eligibility Criteria

Inclusion Criteria

Visual impairment due to choroidal neovascularization (CNV) secondary to PM
Best corrected visual acuity (BCVA) in the study eye > 24 and -6D), anterior-posterior elongation > 26 mm; posterior changes compatible with the pathologic myopia
Either lesion types in the study eye: subfoveal, juxtafoveal, extrafoveal

Exclusion Criteria

Patients with uncontrolled systemic or ocular diseases
Blood pressure > 150/90 mmHg
History of pan-retinal, focal/grid laser photocoagulation or intraocular treatment with any anti-VEGF or vPDT in the study eye
Intravitreal treatment with corticosteroids or intraocular surgery within last 3 months in the study eye

Other protocol-defined inclusion/exclusion criteria may apply

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01217944). 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.