A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IVT MHU650 in Macular Edema Patients
NCT04635800 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2025-05-18
Summary
This was an open-label, multi-center, FIH study with a single ascending dose (SAD) design that assessed the safety, tolerability and pharmacokinetics (PK) of a single IVT dose of MHU650 in up to 24 participants with macular edema.
Conditions
- Macular Edema
- Diabetic Macular Edema
- Neovascular Age-related Macular Degeneration
- Retinal Vein Occlusion
Interventions
- DRUG
-
MHU650
MHU650 powder for solution for injection
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-10
- Primary Completion
- 2022-05-24
- Completion
- 2022-05-24
- FDA Drug
- Yes
Countries
- United States
- Puerto Rico
Study Locations
More Related Trials
-
Exploratory Study to Investigate the Bioactivity, Ocular and Systemic Safety, Tolerability, and Pharmacokinetics Following Single and Multiple Intravitreal Administrations of KSI-301 in Subjects With wAMD, DME and RVO
NCT03790852 ·Status: TERMINATED ·Phase: PHASE1
-
Study of MP0112 Intravitreal Injection in Patients With Diabetic Macular Edema
NCT01042678 ·Status: TERMINATED ·Phase: PHASE1
-
Safety and Tolerability Study for Age-Related Macular Degeneration
NCT01485588 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular Edema
NCT04432831 ·Status: COMPLETED ·Phase: PHASE3
-
Intravitreal Faricimab in Patients With Refractory Macular Edema
NCT07093385 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Tolerability Study of UBX1325 in Patients With Diabetic Macular Edema or Neovascular Age-Related Macular Degeneration
NCT04537884 ·Status: COMPLETED ·Phase: PHASE1
-
A 2-part Study Consisting of a Multiple Ascending Dose Safety Study in Participants With Macular Edema Following Branch Retinal Vein Occlusion and a Dose-finding Safety and Preliminary Efficacy Study in Participants With Either Diabetic Macular Edema or Neovascular Age-related Macular Degeneration
NCT06664502 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7497372 in Participants With Diabetic Macular Edema (DME)
NCT06847854 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion
NCT04740905 ·Status: COMPLETED ·Phase: PHASE3
-
A Randomized, Double-masked, Multicenter,Sham-controlled, Safety and Efficacy Study of KH902 in Patients With Wet AMD
NCT01436864 ·Status: COMPLETED ·Phase: PHASE3
-
Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Intravitreal (IVT) Injection of ABI-110 (AAV2.N54-VEGF Trap) in Subjects With Neovascular (Wet) Age-Related Macular Degeneration (wAMD), Including Symptomatic Macular Polypoidal Choroidal Vasculopathy (PCV)
NCT06550011 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
A Study of Single Intravitreal Injection HB002.1M in Subjects With Neovascular Age-Related Macular Degeneration
NCT03387566 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion
NCT04740931 ·Status: COMPLETED ·Phase: PHASE3
-
A Dose-masked Study of Intravitreal EYE103 in Participants With NVAMD or Macular Edema Following BRVO
NCT07205887 ·Status: RECRUITING ·Phase: PHASE2
-
Safety and Efficacy of AGN208397 in the Treatment of Macular Edema Associated With Retinal Vein Occlusion (RVO)
NCT01027650 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Evaluation the Pharmacokinetics, Safety, Tolerability of TK001 in Patients With Neovascular Age-related Macular Degeneration
NCT02613559 ·Status: UNKNOWN ·Phase: PHASE1
-
Safety of BBC1501 Intravitreal Injection in Patients With Neovascular Age-Related Macular Degeneration (nAMD)
NCT05803785 ·Status: RECRUITING ·Phase: PHASE1
-
4D-150 in Patients With Neovascular (Wet) Age-Related Macular Degeneration
NCT05197270 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Safety and Efficacy of Intravitreal LFG316 in Wet Age Related Macular Degeneration (AMD)
NCT01535950 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerability and PK of Subcutaneous D-4517.2 in Subjects With Wet AMD or DME
NCT05387837 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Safety and Tolerability Study of Intravitreal VEGF-Trap Administration in Patients With Neovascular AMD
NCT00320775 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase I/II Safety Study of DE-120 Injectable Solution for Age-related Macular Degeneration
NCT02022501 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study of RO6867461 Administered in Single- and Multiple-Ascending Doses in Patients With Wet Age-Related Macular Degeneration
NCT01941082 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Intravitreal (IVT) REGN910-3 and IVT REGN910 in Patients With Either Neovascular ("Wet") Age Related Macular Degeneration (AMD) or Diabetic Macular Edema (DME)
NCT01997164 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of IBI302 Injection in nAMD or DME
NCT05961007 ·Status: SUSPENDED ·Phase: PHASE1/PHASE2