MATISSE STUDY
Research type
Research Study
Full title
An Open-Label Dose Escalation Study of PF-04523655 (Stratum I) Combined With A Prospective, Randomized, Double-Masked, Multi-Center, Controlled Study (Stratum II) Evaluating The Efficacy and Safety of PF-04523655 Alone and in Combination with Ranibizumab Versus Ranibizumab Alone in Diabetic Macular Edema (MATISSE STUDY)
IRAS ID
97092
Contact name
Clare Bailey
Sponsor organisation
Quark Pharmaceuticals, Inc.
Eudract number
2011-004157-66
Clinicaltrials.gov Identifier
Research summary
This is a Quark Pharmaceuticals sponsored study, in patients with Diabetic Macular Edema (DME). Approximately 4% of the world??s population is affected by diabetes mellitus (DM) and almost half of this group will develop diabetic retinopathy (DR), cause of blindness.This is a two-part study, (Stratum I and Stratum II).If patients are eligible and wish to take part, they will be enrolled into one of the parts (Strata) Stratum I Up to 24 subjects with low vision will be enrolled into Stratum I receiving a single IVT injection of PF-04523655 (6, 9, 12mg) in 3 cohorts. If 6mg of PF-04523655 not tolerated, a dose of 4.5mg will be administered to a second cohort of subjects and there will be no third cohort. If the 6mg is well tolerated Stratum I will continue to the second cohort with 9mg PF-04523655. Only 1 subject will receive PF-04523655 in any 24 hour period. Once the last subject in a cohort has received treatment a 7 day follow up period and safety data review is required before the first subject is enrolled into the next cohort and to determine the dose to be administered in Stratum II. Stratum II Approximately 240 subjects with DME will be randomized across 4 cohorts. Subjects will receive either 0.5mg ranibizumab alone or 3mg PF-04523655 with 0.5mg ranibizumab (cohort 1 and 2) If 6mg dose of PF-04523655 is well tolerated in Stratum I subjects, cohort 3 subjects will receive 6mg PF-04523655 in combination with 05.mg ranibizumab and cohort 4 will receive 6mg PF-04523655 alone. If 4.5mg PF-04523655 is administered in Stratum I subjects, Stratum II subjects in cohort 3 will be administered 4.5mg PF-04523655 in combination with 0.5mg ranibizumab and subjects in cohort 4 will receive 4.5mg PF-04523655 alone. Stratum II subjects will receive 6 monthly IVT injections treatment of PF-04523655 and or ranibizumab. Response to treatment will be assessed monthly. Month 3 onwards, subjects receiving PF-04523655 alone will be eligible for rescue treatment if they meet the rescue criteria. All rescued subjects will receive ranibizumab injections for 6 additional months (as in the other groups of the study) The main objective is to determine the safety, dose limiting toxicities and the PK of a single IVT injection of PF-04523655 (Stratum I). Also to evaluate the safety and efficacy of PF-04523655 alone and with ranibizumab to improve visual acuity in patients with DME (Stratum II) The study will be conducted in approximately 50 sites in Europe and other countries including the US and Israel. Patients will be recruited from hospital clinics and need to attend regular visits to receive treatment and be examined by their doctors. Taking part may or may not benefit a patient??s health. It is hoped that this study will contribute further information towards appropriate treatments for patients with DME.
REC name
London - Harrow Research Ethics Committee
REC reference
12/LO/0250
Date of REC Opinion
8 May 2012
REC opinion
Further Information Favourable Opinion