NCT01445899

PF-04523655 Dose Escalation Study, and Evaluation of PF-04523655 With/Without Ranibizumab in Diabetic Macular Edema (DME)

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 258 (actual)
• Sponsor: Quark Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a two-part study. The first part (Stratum I) is an open-label, dose escalation, safety, tolerability and pharmacokinetic study, where active study drug (PF-04523655) will be given to all patients who participate. Stratum I will determine the maximum tolerated dose and any dose-limiting toxicities. The second part (Stratum II) is a prospectively randomized, multi-center, double-masked, dose ranging study evaluating the efficacy and safety of PF-04523655 alone and in combination with ranibizumab versus ranibizumab alone in patients with DME.

Detailed description

Patients will be enrolled concurrently according to one of two sets of criteria designated as Stratum I and Stratum II. 1. Stratum I will enroll up to 24 subjects with low vision, inclusive of possible intermediate doses, in up to 4 cohorts of 3-6 evaluable subjects. 2. Stratum II will enroll approximately 240 subjects with DME 1:1:1:1 in up to 4 cohorts of 60 evaluable subjects.

Conditions

• Choroidal Neovascularization
• Diabetic Retinopathy
• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	PF-04523655 (Stratum I)	PF-04523655 (a small interfering RNA) - a single IVT injection
DRUG	ranibizumab	6 monthly IVT injections of ranibizumab (Stratum II)
DRUG	PF-04523655 (Stratum II)	6 monthly IVT injections of PF-04523655 (a small interfering RNA)

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2011-10-04
• Last updated: 2015-02-23

Locations

51 sites across 7 countries: United States, Belgium, Czechia, Germany, Israel, Poland, United Kingdom