Greater Manchester Avastin® for choroidal Neovascularisation trial

Not Applicable

Completed

• Conditions: Age-related macular degeneration; Eye Diseases; Other retinal disorders

• Registration Number: ISRCTN34221234
• Lead Sponsor: Central Manchester & Manchester Children's Hospital NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-31
• Last Update Posted: 8 May 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

1. Men or women of any ethnic background over the age of 50 years with AMD
2. Subfoveal choroidal neovascularisation or juxtafoveal choroidal neovascularisation where laser would ablate the centre of the foveal avascular zone (FAZ)
3. Predominantly-classic CNV or minimally classic or occult with no classic CNV lesion composition where there is evidence of recent disease progression (i.e. vision loss, lesion growth on fundus fluorescein angiogram [FFA], progression on optical coherence tomography [OCT] examination, new blood associated with lesion within the preceding three months)
4. The total area of CNV within the lesion (including classic and occult components) must be greater than 50% of the lesion area as defined by FFA
5. The BCVA letter score must be between logMAR 0.3?1.2 (approximately 6/12 to 6/96 Snellen equivalent)
6. Patients must have completed study consent forms and must be willing and able to comply with all of the study protocols

Exclusion Criteria

1. Prior treatment to the CNV lesion
2. Lesion components including fibrosis, haemorrhage or serous pigment epithelial detachment representing greater than 50% of the lesion
3. Retinal pigment epithelial tear (rip)
4. Active intraocular inflammation within one month of screening for study
5. Active or suspected ocular or periocular infection
6. Uncontrolled glaucoma in study eye (intra-ocular pressure [IOP] of greater than 25 mmHg despite anti-glaucomatous medication)
7. History of ocular surgery or YAG (yttrium aluminium garnet) laser capsulotomy within two months of screening for study
8. History of allergy to fluorescein
9. Any systemic medication that may interfere with the safety of the patient or is known to be toxic to the retina
10. Uncontrolled hypertension
11. Within one month of major surgery
12. History of myocardial infarction, stroke or gastrointestinal perforation
13. Episode of angina or transient ischaemic attack within 6 months of screening
14. Pregnant and or lactating women
15. Women of childbearing potential (i.e. not sterilised or not post menopausal) who are unwilling to use effective contraception during the study and for 6 months after Bevacizumab treatment has stopped
16. Men with a spouse or partner with childbearing potential unless the participant has agreed to use condoms

Study & Design

• Study Type: Interventional
• Study Design: Not specified