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| 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 |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN83325075 |
| Date ISRCTN assigned | 29/11/2006 |
| Local reference number(s) | REC reference number 06/Q0504/46. EudraCT number 2006-001544-31 |
| Public title | 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 |
| Scientific title | |
| Acronym | ABC |
| Disease/condition/study domain | Choroidal neovascualrisation (CNV) secondary to age-related macular degeneration (AMD) |
| Study hypothesis | 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 Neo-Vascularisation (CNV) due to Age-related Macular Degeneration (AMD). |
| Design/methodology | Prospective, double masked, randomised, controlled trial |
| Research ethics review | Moorfields and Whittington Local Research Ethics Committee, date of approval 14 July 2006 (ref: 06/Q0504/46). |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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 |
| Patient information material | |
| Anticipated start date | 11/08/2006 |
| Anticipated end date | 01/12/2007 |
| Status of trial | Completed |
| Target number of participants | 130 |
| Interventions | 1. Intravitreal Avastin® (bevacizumab) with placebo PDT where necessary to maintain masking 2. Verteporfin PDT with sham intravitreal inection 3. Intravitreal Macugen® (pegaptanib sodium) 4. Sham intravitreal injection |
| Primary outcome measure(s) | The proportion of subjects who gain more than 15 letters (approximately three lines) of best corrected visual acuity score at the 12 month time point compared with baseline, based on the ETDRS visual acuity chart and assessment at a starting distance of 4 m. |
| Secondary outcome measure(s) | 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. 3. Mean change in central OCT thickness. 4. 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. |
| Sources of funding | The Special Trustees of Moorfields Eye Hospital NHS Foundation Trust (UK) |
| Sponsor name | Moorfields Eye Hospital NHS Foundation Trust (UK) |
| Sponsor details | 162 City Road London United Kingdom EC1V 2PD |
| Sponsor telephone | +44 (0)20 7566 2816 |
| Sponsor fax | +44 (0)20 7608 6925 |
| Sponsor email | sue.lydeard@moorfields.nhs.uk |
| Sponsor website | http://www.moorfields.nhs.uk/Home |
| Contact name | Mr Adnan Tufail |
| Contact details | Moorfields Eye Hospital NHS Foundation Trust 162 City Road London United Kingdom EC1V 2PD |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN83325075 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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