Choroidal neovascularisation in pathologic myopia: intravitreal ranibizumab versus bevacizumab
| ISRCTN | ISRCTN49803272 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49803272 |
| Secondary identifying numbers | 01/2008 |
- Submission date
- 11/09/2009
- Registration date
- 01/10/2009
- Last edited
- 01/10/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Magda Gharbiya
Scientific
Scientific
Department of Ophthalmology
La Sapienza University of Rome
Viale del Policlinico
Rome
155-00161
Italy
| magda.gharbiya@uniroma1.it |
Study information
| Study design | Single-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Choroidal neovascularisation in pathologic myopia: intravitreal ranibizumab versus bevacizumab - a randomised controlled trial |
| Study acronym | N|A |
| Study objectives | 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(s) | Ethics Committee of the Department of Ophthalmology, La Sapienza University of Rome, approved in January 2008 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ranibizumab (Lucentis®), bevacizumab (Avastin®) |
| Primary outcome measure | 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 study start date | 01/02/2008 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2008 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Italy
Study participating centre
Department of Ophthalmology
Rome
155-00161
Italy
155-00161
Italy
Sponsor information
La Sapienza University of Rome (Italy)
University/education
University/education
Viale del Policlinico 155
Rome
00161
Italy
| magda.gharbiya@uniroma1.it | |
| Website | http://www.uniroma1.it/ |
"ROR" |
https://ror.org/02be6w209 |
Funders
Funder type
University/education
La Sapienza University of Rome (Italy) - Department of Opthalmology
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
