Choroidal neovascularisation in pathologic myopia: intravitreal ranibizumab versus bevacizumab

Completed

Conditions: Other disorders of choroid
Myopic choroidal neovascularisation
Eye Diseases

Registration Number: ISRCTN49803272

Lead Sponsor: a Sapienza University of Rome (Italy)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>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. <br><br>All primary and secondary outcomes were assessed at study entry and monthly during follow-up (total duration of follow-up: two years).

Secondary Outcome Measures

Name	Time	Method
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. <br><br>All primary and secondary outcomes were assessed at study entry and monthly during follow-up (total duration of follow-up: two years).