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

A 12 Month, Phase III, Randomized, Double-masked, Multicenter, Active-controlled Study to Evaluate the Efficacy and Safety of Two Different Dosing Regimens of 0.5 mg Ranibizumab vs. Verteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/003003

Enrollment

275

Registered

2011-02-04

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Pathological Myopia

Interventions

Intervention1: ranibizumab (driven by disease activity): 0.5 mg ranibizumab intravitreal injections given once in one month depending on disease activity. Intervention2: ranibizumab (driven by stabili

Eligibility

Inclusion criteria

Inclusion criteria: Visual impairment due to CNV secondary to PM. Best corrected visual acuity in the study eye greater than 24 and less than 78 ETDRS letters High myopia (greater than -6D), anterio-posterior elongation greater than 26 mm; posterior changes compatible with the pathologic myopia Either lesion types in the study eye: subfoveal, juxtafoveal, extrafoveal

Exclusion criteria

Exclusion criteria: * Patients with uncontrolled systemic or ocular diseases * Blood pressure greater than 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

Design outcomes

Primary

Measure	Time frame
Average level of BCVA (letters) over all monthly post-baseline assessments from Month 1 to Month 3 and the baseline level of BCVA.Timepoint: 6 and 12 Months	—

Secondary

Measure	Time frame
Average level of BCVA (letters) over all monthly post-baseline assessments from Month 1 to Month 12 and the baseline level of BCVA and based on the time course of BCVA changes from baselineTimepoint: 6 and 12 months;Compare the proportion of patients with greater than or equal to 10 and greater than or equal to 15 letters gain or reaching 84 letters, and greater than or equal to 10 and greater than or equal to 15 letters loss for each month between treatment groupsTimepoint: 6 and 12 months;Compare the proportion of patients with presence of active leakage over time up to Month 12 in the treatment groupsTimepoint: 6 and 12 months;Difference between the average level of BCVA (letters) over all monthly post-baseline assessments from Month 1 to Month 6 and the baseline level of BCVA.Timepoint: 6 and 12 months;Number, severity, and relationship to the study drug of the Adverse events as measure of safety and tolerability of 0.5 mg ranibizumab (two regimens) vs. vPDT at Month 3, Month 6 and Month 12.Timepoint: 6 and 12 months	—

Measure

Time frame

Average level of BCVA (letters) over all monthly post-baseline assessments from Month 1 to Month 12 and the baseline level of BCVA and based on the time course of BCVA changes from baselineTimepoint: 6 and 12 months;Compare the proportion of patients with greater than or equal to 10 and greater than or equal to 15 letters gain or reaching 84 letters, and greater than or equal to 10 and greater than or equal to 15 letters loss for each month between treatment groupsTimepoint: 6 and 12 months;Compare the proportion of patients with presence of active leakage over time up to Month 12 in the treatment groupsTimepoint: 6 and 12 months;Difference between the average level of BCVA (letters) over all monthly post-baseline assessments from Month 1 to Month 6 and the baseline level of BCVA.Timepoint: 6 and 12 months;Number, severity, and relationship to the study drug of the Adverse events as measure of safety and tolerability of 0.5 mg ranibizumab (two regimens) vs. vPDT at Month 3, Month 6 and Month 12.Timepoint: 6 and 12 months

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Countries

Austria, Canada, France, Germany, Hungary, India, Italy, Japan, Latvia, Lithuania, Poland, Portugal, Republic of Korea, Singapore, Slovakia, Spain, Switzerland, Turkey, United Kingdom

Contacts

Public ContactMurugananthan K

murugananthan.k@novartis.com022-24958545

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026