A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IVT MHU650 in Macular Edema Patients

• Status: Recruiting
• Trial end date: 2022-03-25
• Target enrollment: 0
• Participant gender: All

Summary

This open-label study is being conducted to evaluate the initial safety and tolerability of IVT MHU650 in patients with DME, AMD, or RVO. The primary objective of this study is to evaluate the safety and tolerability of single ascending doses of IVT MHU650 in patients with macular edema. The secondary objective of this study is to evaluate the serum pharmacokinetic profile of total MHU650 following single IVT dose of MHU650 in macular edema patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Key Inclusion Criteria:

• Patients with macular edema in at least one eye, including those with focal or diffuse diabetic macular edema (DME), neovascular age-related macular degeneration (AMD), or retinal vein occlusion (RVO), in the opinion of the investigator:

• Early Treatment Diabetic Retinopathy (ETDRS) letter score in the study eye must be worse than 60 letters (20/63) but better than 24 letters (20/320) at screening and baseline. The ETDRS score in the non-study eye should be ≥ 60 letters at screening and baseline.

• Sufficiently clear ocular media and adequate pupil dilation to permit fundus photographs of adequate clarity to measure diameters of retinal arteries and veins

• Vital signs as specified in the protocol

Key Exclusion Criteria:

• Proliferative diabetic retinopathy in the study eye

The following is permitted as an exception:

• Tufts of neovascularization less than one disc area with no vitreous hemorrhage

• Focal, peripheral retinal areas treated with photocoagulation with fewer than 30 laser burns performed at least 6 months preceding Day 1

• Patients with type 1or type 2 diabetes who have hemoglobin A1C of ≥ 12 at screening

• Other ocular conditions as specified in the protocol

• Systemic conditions as specified in the protocol

Other protocol-defined inclusion/exclusion criteria may apply