A randomised, double-masked phase III study of the efficacy and safety of Avastin® (bevacizumab) intravitreal injections compared to best available therapy in subjects with choroidal neovascularisation secondary to age-related macular degeneration
| ISRCTN | ISRCTN83325075 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83325075 |
| EudraCT/CTIS number | 2006-001544-31 |
| Secondary identifying numbers | REC reference number 06/Q0504/46. EudraCT number 2006-001544-31 |
- Submission date
- 27/10/2006
- Registration date
- 29/11/2006
- Last edited
- 10/05/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Adnan Tufail
Scientific
Scientific
Moorfields Eye Hospital NHS Foundation Trust
162 City Road
London
EC1V 2PD
United Kingdom
Study information
| Study design | Prospective, double masked, randomised, controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | ABC |
| Study objectives | To determine the efficacy and safety of intravitreal Avastin® (bevacizumab) intravitreal injections compared to usual care (verteporfin photodynamic therapy, Macugen® or sham) in treating choroidal neovascularisation (CNV) due to age-related macular degeneration (AMD). Please note that, as of 24/09/2008, the anticipated end date of this trial has been updated from 01/12/2007 to 05/12/2008. |
| Ethics approval(s) | Moorfields and Whittington Local Research Ethics Committee, date of approval 14 July 2006 (ref: 06/Q0504/46). Added as of 06/10/2008: An additional approval has been granted from the Guy's Research Ethics Committee on the 5th April 2007 to allow recruitment at additional trial sites within the UK (ref: 07/Q0704/20). |
| Health condition(s) or problem(s) studied | Choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD) |
| Intervention | 1. Intravitreal Avastin® (bevacizumab) with placebo PDT where necessary to maintain masking 2. Verteporfin PDT with sham intravitreal injection 3. Intravitreal Macugen® (pegaptanib sodium) 4. Sham intravitreal injection |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Avastin® (bevacizumab), verteporfin, Macugen® (pegaptanib sodium) |
| Primary outcome measure | The proportion of subjects who gain 15 letters (3 lines) or more of best corrected visual acuity score at the 12 month timepoint compared with baseline, based on the ETDRS visual acuity chart and assessment at a starting distance of 4 m. |
| Secondary outcome measures | Secondary outcome measures amended as of 24/09/2008: 1. The proportion of subjects who lose fewer than 15 letters (approximately 3 lines), the proportion who have gained 5 letters or more (1 line), and the proportion who have gained 10 letters or more (2 lines) in the best corrected visual acuity score at 12 months compared with baseline, based on the ETDRS visual acuity chart and assessment at a starting distance of 4 m 2. The proportion of patients who meet these visual criteria at 6 months 3. To evaluate the safety and tolerability of intravitreal injections of Avastin® given every 6 weeks 4. Mean change in central OCT thickness 5. If the study is continued after the analysis of data at 12 month timepoint, after the second treatment year of the study, the same objectives will be analysed on unmasked data Previous secondary outcome measures: 1. The proportion of subjects who lose fewer than 15 letters (approximately three lines) and the proportion who have gained five letters or more (one line) in the best corrected visual acuity score at 12 months compared with baseline, based on the ETDRS visual acuity chart and assessment at a starting distance of 4 m 2. The proportion of patients who meet these visual criteria at six months 3. To evaluate the safety and tolerability of intravitreal injections of Avastin® given every six weeks 4. Mean change in central OCT thickness 5. If study is continued after the analysis of data at 12 month time point then after the second treatment year of the study, the same objectives will be analysed on unmasked data |
| Overall study start date | 11/08/2006 |
| Completion date | 05/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 130 |
| Key inclusion criteria | 1. Aged over 50 years 2. Primary or subfoveal CNV lesions secondary to AMD in the study eye 3. An occult lesion must have presumed evidence of disease progression, defined as one or more of the following: a. deterioration of best corrected vision by one Snellen line or five letters on Early Treatment Diabetic Retinopathy Study (ETDRS) chart within the past three months due to progression of CNV b. presence of sub- or intra-retinal blood c. growth of lesion size on the angiogram by more than 10% in the past three months AND evidence of increased central macular thickness on Optical Coherence Tomography (OCT) 4. Area of sub-retinal blood less than 50% of total lesion area 5. Best corrected visual acuity, using ETDRS charts, of 20/40 (6/12) to 20/320 (6/96) Snellen equivalent in the study eye 6. Total lesion size less than 12 disc areas including all contiguous lesion components 7. Area of fibrosis less than 25% of the total lesion area |
| Key exclusion criteria | Ocular: 1. Sub-retinal haemorrhage in the study eye that involves the centre of the fovea, if the size of the haemorrhage is either more than 50% of the total lesion area or more than one disc areas in size 2. Subfoveal fibrosis or atrophy in the study eye 3. CNV in either eye due to causes other than AMD, such as ocular histoplasmosis, trauma, or pathologic myopia 4. Retinal pigment epithelial tear involving the macula in the study eye 5. Prior treatment with external-beam radiation therapy, Transpupillary Thermal Therapy (TTT), thermal laser, or Photo-Dynamic Therapy (PDT) in the study eye or history of submacular surgery or other surgical intervention for AMD in the study eye 6. PDT in the non-study eye less than seven days preceding day zero 7. Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (Macugen®, Avastin®, anecortave acetate, protein kinase C inhibitors, etc.) 8. Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye 9. Amblyopia, infective conjunctivitis or scleritis, glaucoma, corneal disease, inflammatory eye disease 10. Diabetic retinopathy more than mild nonproliferative in the fellow eye as defined by the ETDRS or any diabetic maculopathy 11. Intraocular surgery (including cataract surgery) in the study eye within two months preceding day zero 12. Aphakia or absence of the posterior capsule in the study eye 13. Previous violation of the posterior capsule in the study eye is also excluded unless it occurred as a result of Yttrium Aluminum Garnet (YAG) posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation 14. Spherical equivalent of the refractive error in the study eye demonstrating more than -8 diopters of myopia or signs of pathologic myopia with a refraction of 4-8 diopters 15. For subjects who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye cannot exceed -8 diopters of myopia Systemic: 1. Recent stroke (last six months), or cardiac event (last six months), uncontrolled angina or uncontrolled hypertension 2. Current treatment for active systemic infection 3. Unable to give informed consent 4. Anticoagulant treatment (anti-platelet drugs allowed) 5. Fluorescein or Indo-Cyanine Green (ICG) allergy 6. Pre-menopausal women not using adequate contraception; the following are considered effective means of contraception: surgical sterilisation, use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an Intra-Uterine Device (IUD), or contraceptive hormone implant or patch |
| Date of first enrolment | 11/08/2006 |
| Date of final enrolment | 05/12/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Moorfields Eye Hospital NHS Foundation Trust
London
EC1V 2PD
United Kingdom
EC1V 2PD
United Kingdom
Sponsor information
Moorfields Eye Hospital NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
162 City Road
London
EC1V 2PD
England
United Kingdom
| Phone | +44 (0)20 7566 2816 |
|---|---|
| sue.lydeard@moorfields.nhs.uk | |
| Website | http://www.moorfields.nhs.uk/Home |
"ROR" |
https://ror.org/03zaddr67 |
Funders
Funder type
Government
The Special Trustees of Moorfields Eye Hospital NHS Foundation Trust (UK)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 09/06/2010 | Yes | No | |
| Results article | results | 11/05/2011 | Yes | No | |
| Results article | results | 09/03/2012 | Yes | No |
