Condition category
Eye Diseases
Date applied
11/09/2009
Date assigned
01/10/2009
Last edited
01/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Magda Gharbiya

ORCID ID

Contact details

Department of Ophthalmology
La Sapienza University of Rome
Viale del Policlinico
Rome
155-00161
Italy
magda.gharbiya@uniroma1.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01/2008

Study information

Scientific title

Choroidal neovascularisation in pathologic myopia: intravitreal ranibizumab versus bevacizumab - a randomised controlled trial

Acronym

N|A

Study hypothesis

Choroidal neovascularisation (CNV) secondary to pathologic myopia (PM) is a known cause of severe visual loss for young and middle-aged patients. Nearly 10% of patients with degenerative retinal findings consistent with high myopia develop choroidal neovascularisation. Although the natural course of myopic CNV is highly variable, the long-term prognosis is known to be poor.

This study compares the efficacy and safety of intravitreal injection of ranibizumab versus bevacizumab in patients with myopic choroidal neovascularisation.

Ethics approval

Ethics Committee of the Department of Ophthalmology, La Sapienza University of Rome, approved in January 2008

Study design

Single-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Myopic choroidal neovascularisation

Intervention

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 one eye. If both eyes were eligible, the eye with worse visual acuity (VA) was the study eye unless the other eye was deemed more suitable for medical reasons. Both drugs were administered as needed after the first injection.

Intervention type

Drug

Phase

Not Applicable

Drug names

Ranibizumab (Lucentis®), bevacizumab (Avastin®)

Primary outcome measures

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 outcome measures

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).

Overall trial start date

01/02/2008

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

40

Participant 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

Recruitment start date

01/02/2008

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Italy

Trial participating centre

Department of Ophthalmology
Rome
155-00161
Italy

Sponsor information

Organisation

La Sapienza University of Rome (Italy)

Sponsor details

Viale del Policlinico 155
Rome
00161
Italy
magda.gharbiya@uniroma1.it

Sponsor type

University/education

Website

http://www.uniroma1.it/

Funders

Funder type

University/education

Funder name

La Sapienza University of Rome (Italy) - Department of Opthalmology

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes