GX29176 Lampalizumab in Geographic Atrophy
Research type
Research Study
Full title
A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, SHAM-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF LAMPALIZUMAB ADMINISTERED INTRAVITREALLY TO PATIENTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE RELATED MACULAR DEGENERATION
IRAS ID
164686
Contact name
Head, EU/ROW Regulatory Affairs Pharmaceutical Division
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2014-000107-27
Duration of Study in the UK
3 years, 11 months, 11 days
Research summary
Age-related macular degeneration (AMD) is the leading cause of irreversible blindness in people aged 50 years or older in the developed world. The majority of the visual loss occurs in the advanced stage of AMD. Geographic atrophy (GA) is one form of the condition, which is characterised by loss of blood vessels to the retina, layers of cells that contain pigment, and photoreceptors in the retina. The prevalence of GA increases exponentially with age and approximately quadruples per decade beyond 50 years of age. The estimated prevalence of GA in populations of European ancestry at 70 years of age is 0.70%, rising to 2.91% at 80 years of age and 11.29% at 90 years of age.
Currently, there are no approved treatments to prevent the worsening of GA or the associated decline in vision. Consequently, a significant unmet need exists for the treatment of this serious condition.
This study aims to assess the efficacy and safety of a 10 mg lampalizumab injection (into the inside of the eye), given either 4 weekly or 6 weekly, compared to a sham injection for a treatment period of approximately 2 years in patients with geographic atrophy secondary to age related macular degeneration.
A total of approximately 936 patients will be recruited into the study globally. Which treatment a participant receives will be decided by chance by a computer.
In the UK, it is expected that 53 patients will be enrolled from 8 participating centres.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
14/SC/1426
Date of REC Opinion
6 Feb 2015
REC opinion
Further Information Unfavourable Opinion