A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IVT MHU650 in Macular Edema Patients
Macular Edema, Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
About this trial
This is an interventional treatment trial for Macular Edema focused on measuring Macular degeneration, age-related macular degeneration, dry macular degeneration, wet macular degeneration, Diabetic Macular Edema, DME, Neovascular age-related macular edema, nAMD, Retinal Vein Occlusion, RVO, MHU650, macular edema
Eligibility 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
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Cohort 1; open-label, non-randomized, single administration
Cohort 2; open-label, non-randomized, single administration
Cohort 3, open-label; non-randomized, single administration
Cohort 4, open-label, non-randomized, single administration