Date: 2014-09-15
Type of
information: Results
phase: 3
Announcement: initiation of the trial
Company: Roche (Switzerland)
Product: lampalizumab
Action
mechanism:
Disease: geographic atrophy (GA - advanced form of dry age-related macular degeneration (AMD)
Therapeutic
area: Ophtalmological diseases
Country:
Trial
details:
- The phase III trials, called Chroma (GX29176 -NCT02247479) and Spectri (GX29185 -NCT02247531), are identically-designed, double-masked, randomized studies comparing 10 mg dose of lampalizumab administered every 4 or 6 weeks by intravitreal injection to sham injections. Approximately 936 patients will be enrolled in each study (188 biomarker-positive patients and 124 biomarker-negative patients each for the sham, lampalizumab q4w, and lampalizumab q6w treatment groups, in each study). The studies will recruit patients from approximately 300 physician-investigator sites in 24 countries worldwide. Key inclusion criteria are similar to that of the phase II MAHALO study and include the presence of geographic atrophy in both eyes with no history of neovascular (wet) AMD.
The primary objective of the studies is to demonstrate a reduction in the rate of GA disease progression. This efficacy endpoint, evaluated at one year (week 48), is defined as the mean change in the GA lesion area of the chosen study eye from baseline, as measured by fundus autofluorescence (FAF), an imaging technique used to provide information about the size and type of GA lesions in the macula. Secondary objectives of the studies, planned for evaluation at two years (96 weeks), focus on assessing the impact of lampalizumab treatment on patients’ visual function. If successful, long-term follow-up of patients completing Chroma and Spectri is planned to continue through a subsequent, open-label extension study.As analysis of the MAHALO phase II study suggested that the treatment effect with lampalizumab might be stronger in patients positive for the CFI genetic biomarker; therefore, this biomarker will continue to be investigated in phase III.
Latest
news:
- • On September 8, 2017, Roche announced that the primary endpoint has not been met in Spectri, the first of two phase III studies evaluating the safety and efficacy of lampalizumab, an investigational medicine for the treatment of geographic atrophy (GA) due to age-related macular degeneration (AMD). Lampalizumab did not reduce mean change in GA lesion area compared to sham treatment at 1 year (48 weeks). Given the lack of efficacy, further dosing in patients will be interrupted until the results from the
second phase III study are evaluated. Results of the second phase III study, Chroma, are anticipated in November.
- • On September 15, 2014, Roche announced that phase III clinical studies have been initiated for lampalizumab, an investigational drug for geographic atrophy (GA), the advanced form of age-related macular degeneration (AMD), a progressive condition which can result in blindness. The phase III study program will evaluate the safety and efficacy of lampalizumab and its potential to slow the progression of GA. The studies will also further explore if people with a specific genetic biomarker, a mutation in complement factor I, may benefit more from lampalizumab treatment. The trial design was released at the 14th EURETINA Congress 2014 in London. The MAHALO phase II primary endpoint showed a 20 percent reduction in GA lesion progression in patients treated monthly with lampalizumab as compared with sham at month 18.1 Additionally, data from a sub-population of GA patients receiving monthly lampalizumab and positive for the complement factor I (CFI) biomarker, demonstrated a 44 percent decrease in the rate of disease progression at 18 months. This exploratory biomarker analysis will be further evaluated in the phase III program.
Is
general: Yes
