A 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

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

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221328

Enrollment

275

Registered

2010-12-03

Start date

2010-12-03

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Visual impairment due to choroidal neovascularization secondary to pathologic myopia

Interventions

investigational material(s) Generic name etc : ranibizumab INN of investigational material : Therapeutic category code : 131 Agents for ophthalmic use Dosage and Administration for Investigational ma

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or Female patients 18 years old and older, and written informed consent is given 2. Visual impairment due to CNV secondary to PM 3. Best corrected visual acuity in the study eye > 24 and -6D), anterio-posterior elongation > 26 mm, and posterior changes compatible with the pathologic myopia 5. Either lesion types in the study eye: subfoveal, juxtafoveal, extrafoveal

Exclusion criteria

Exclusion criteria: -Patients with uncontrolled systemic or ocular diseases -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 -Blood pressure > 150/90 mmHg Other protocol-defined inclusion/exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
Average level of BCVA over all monthly post-baseline assessments from Month 1 to Month 3 and the baseline level of BCVA be compared between treatment groups	—

Secondary

Measure	Time frame
-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 -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 baseline -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 more than or equal to 10 and more than or equal to 15 letters loss for each month between treatment groups -Compare the proportion of patients with presence of active leakage over time up to Month 12 in the treatment groups -Number, severity, and relationship to the study drug of the Adverse events be compared between treatment groups	—

Measure

Time frame

-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 -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 baseline -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 more than or equal to 10 and more than or equal to 15 letters loss for each month between treatment groups -Compare the proportion of patients with presence of active leakage over time up to Month 12 in the treatment groups -Number, severity, and relationship to the study drug of the Adverse events be compared between treatment groups

—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026