Abicipar Pegol in Neovascular age related macular degeneration
Research type
Research Study
Full title
Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration
IRAS ID
183061
Contact name
Andrew Lotery
Contact email
Sponsor organisation
Allergan Ltd.
Eudract number
2014-004580-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 8 months, 3 days
Research summary
Allergan is currently developing Abicipar Pegol as a treatment for neovascular age-related macular degeneration (AMD). AMD is the leading cause of severe vision loss in people aged over 65 years in the US and other western countries, and without treatment results in an average loss of around 4 lines of visual acuity within two years of disease onset.
The presence of a substance called vascular endothelial growth factor-A (VEGF-A) is implicated in the development and maintenance of the new blood vessels that are characteristic of the neovascular form of AMD. Highly specific and targeted anti-VEGF based therapies have therefore been developed and there are currently three agents approved across many countries for the treatment of neovacsular AMD; pegaptanib sodium, ranibizumab and aflibercept. These agents are delivered to the back of the eye by injection (intravitreal injection). However, one drawback of these treatments is the need to frequently deliver the intravitreal injections. In comparison, the regimen for treatment with abicipar pegol is anticipated to require injections to be delivered less frequently, thereby removing a significant treatment burden for the patient and their health care providers and decreasing the risk of complications associated with frequent intravitreal injections. In previous studies in people, Abicipar Pegol was safe and well tolerated at varying doses.
Approximately 900 patients 50 years of age or older will be enroled in this study at approximately 200 sites worldwide: 100 patients at 24 sites in the UK. Patients will receive injection of either abicipar pegol (2 mg) at either 8 or 12 week intervals or monthly ranibizumab (0.5 mg) into the back of the eye. Participants will not know which treatment they are receiving. Participants will have approximately 27-31 clinic visits over 2 years. Procedures include: blood and urine samples, vision tests and eye examinations including fluorescein angiography, physical examinations and questionnaires
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
15/SC/0409
Date of REC Opinion
2 Sep 2015
REC opinion
Further Information Favourable Opinion