NCT05390840

A Study to Investigate the Effect on Central Macular Thickness of Treatment With MG-O-1002 Eye Drops in Participants Aged Over 45 With Neovascular Age-related Macular Degeneration (nAMD)

A Phase II Trial to Evaluate the Efficacy and Safety of Topical Ocular MG-O-1002 in Patients With Neovascular Age-Related Macular Degeneration (nAMD)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Theratocular Biotek Co. · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

A 2 parts Phase II study to investigate the effect on central macular thickness of treatment with MG-O-1002 eye drops in participants aged over 45 with neovascular age-related macular degeneration (nAMD)

Detailed description

Neovascular Age-related Macular Degeneration (nAMD) is a serious eye disease and a leading cause of irreversible blindness primarily in the older population. Current treatment with anti-vascular endothelial growth factor (VEGF), while effective, requires intravitreal injection meaning administration that needs to be performed by a specialist ophthalmologist and carries procedural risks. MG-O-1002 can be administered as a topical eye drop providing a potentially safer option that can be self-administered increasing accessibility. This study will evaluate the efficacy and safety of topical ocular use of MG-O-1002 in participants with nAMD.

Conditions

• Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	MG-O-1002	MG-O-1002 ophthalmic solution in one concentration (0.8%) ocular administration 3 drops in study eye
OTHER	Placebo	The placebo is 0.9% saline ocular administration 3 drops in study eye

Timeline

• Start date: 2022-08-09
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2022-05-25
• Last updated: 2024-03-13

Locations

6 sites across 1 country: Thailand