Phase 3
Completed N=457
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)
Source: ClinicalTrials.gov NCT01922102 ↗
Enrolled (actual)
457
Serious AEs
6.6%
Results posted
Jun 2019
Primary outcomePrimary: 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
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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)
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 | — |
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
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. Informational only — not medical advice.