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
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