Myopic choroidal neovascularisation Eye Diseases Other disorders of choroid
Conditions
Interventions
Eligible patients were randomly assigned in a 1:1 ratio to intravitreal injection of ranibizumab (Lucentis®, Genentech, USA) 0.5 mg/0.05 ml or bevacizumab (Avastin®, Genentech, USA) 1.25 mg/0.05 ml in
Sponsors
La Sapienza University of Rome (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both males and females, no age limit 2. Pathologic myopia, defined as axial length more than 26.5 mm 3. Subfoveal or juxtafoveal choroidal neovascularisation (CNV), CNV was classified as juxtafoveal if the lesion was closer than 200 microns but not under the geometric centre of the foveal avascular zone 4. Evidence of leakage from CNV on fluorescein angiography
Exclusion criteria
Exclusion criteria: 1. Prior treatment for CNV 2. Other ocular diseases that could affect the visual acuity 3. Angioid streaks 4. Trauma 5. Choroiditis 6. Hereditary diseases in the study or the fellow eye 7. Aphakia 8. Previous vitreoretinal surgery 9. Prior history of bleeding diathesis 10. Prior cerebrovascular accident 11. Pulmonary embolus or deep venous thrombosis 12. Myocardial infarction or uncompensated coronary artery disease within the past 6 months 13. Major surgery within the prior 6 weeks 14. Ongoing uncontrolled hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Changes in best-corrected visual acuity measured according to a standardised refraction protocol, using the Early Treatment Diabetic Retinopathy Study chart at 4 metres distance by a single, well-trained and experienced orthoptist, who was masked to the study. 2. Changes in foveal centre thickness (microns) measured using the ocular coherence tomography (Stratus® OCT, V4.01, Carl Zeiss Meditec, USA) high-resolution Radial Lines protocol and the Retinal Thickness Map analysis programme. All primary and secondary outcomes were assessed at study entry and monthly during follow-up (total duration of follow-up: two years). | — |
Secondary
| Measure | Time frame |
|---|---|
| The leakage from the CNV was evaluated on fluorescein angiography (ImageNet®, Topcon, Japan), performed by a trained photographer masked to the study, in the late phase (6 - 8 minutes) compared with the early phase (first 1 - 2 minutes). The leakage was compared between the times before and after treatment and was described as absent (CNV closure) or persistent. Recurrence was defined as evidence of leakage from a previously closed CNV. All primary and secondary outcomes were assessed at study entry and monthly during follow-up (total duration of follow-up: two years). | — |
Countries
Italy
Outcome results
None listed