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)

NCT05390840 | Unknown Phase 2 DMC

• 1 other identifier: TO-02C201
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 6

Brief 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)

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in central macular thickness over 12 weeks.

  up to 12 weeks

Secondary Outcomes (6)

• Mean change from baseline in Best-Corrected Visual Acuity over 12 weeks

  up to 12 weeks

• Mean Change from baseline in Visual Field over 12 weeks

  up to 12 weeks

• Mean change from baseline in total area of Choroidal Neovascularization (CNV) over 12 weeks

  up to 12 weeks

• The number of patients needing rescue treatment within 12 weeks

  up to 12 weeks

• The time to rescue treatment for needed patients within 12 weeks

  up to 12 weeks

Study Arms (2)

Part 1 (MG-O-1002)

EXPERIMENTAL

Drug: MG-O-1002; Dose level: 0.8%; Dosage form: ophthalmic solution; Route of administration: topical ocular

Drug: MG-O-1002

Part 2 (MG-O-1002 or Placebo)

PLACEBO COMPARATOR

Arm 1: Drug: MG-O-1002; Dose level: 0.8%; Dosage form: ophthalmic solution; Route of administration: topical ocular Arm 2: Drug: Placebo; Dosage form: ophthalmic solution; Route of administration: topical ocular

Drug: MG-O-1002; Other: Placebo

Interventions

MG-O-1002 DRUG

MG-O-1002 ophthalmic solution in one concentration (0.8%) ocular administration 3 drops in study eye

Part 1 (MG-O-1002); Part 2 (MG-O-1002 or Placebo)

Placebo OTHER

The placebo is 0.9% saline ocular administration 3 drops in study eye

Part 2 (MG-O-1002 or Placebo)

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Part 1:
• Adults aged 45 years or older with a diagnosis of nAMD
• Diagnosis in the study eye of active, pathologic, newly diagnosed and treatment naïve (i.e., no previous anti-VEGF treatment or other surgery in the study eye)
• Visual acuity from 20/25 to 20/200 in the study eye
• Total lesion size (including neovascularization, blood) ≦12 disc areas (30.5 mm2) as assessed by Fluorescein Angiography.
• Demonstrate the ability, or have a family member who is willing and able to, instill topical ocular drops in the study eye.
• Ability to give written informed consent and comply with study procedures.
• Part 2:
• Adults aged 45 years or older with a diagnosis of nAMD.
• Participant with nAMD previously treated with 3 injections of Aflibercept within the preceding 4 months, and received the last injection within 30 to 21 days before visit 1 of this study.
• Demonstrate the ability, or have a family member who is willing and able to, instil topical ocular drops in the study eye.
• Ability to give written informed consent and comply with study procedures.

You may not qualify if:

• Part 1:
• Prior use within the last 2 months, or a high possibility of requiring treatment with anti-VEGF therapy (except the study drug) in both eyes during the study.
• Abnormal regions identified by Fundus Autofluorescence (FAF) and Optical Coherence Tomography (OCT) involving the center of the fovea are caused by retinal pigment epithelium (RPE) atrophy, RPE tear, photoreceptor attenuation, or fibrosis/scar tissue.
• Significant retinal serous pigment epithelial detachment (PED) involving the fovea.
• History of, or current clinical evidence in the study eye of aphakia, diabetic macular edema, any ocular inflammation or infection, pathological myopia, retinal detachment, advanced glaucoma, and/or significant media opacity, including cataract.
• History or evidence of the following surgeries in the study eye: penetrating keratoplasty or vitrectomy; corneal transplant; corneal or intraocular surgery within 3 months of Screening.
• Uncontrolled hypertension despite the use of antihypertensive medications.
• Diagnosis of Type 1 or Type 2 diabetes.
• Use of medications that in the opinion of the Investigator could interfere with study results.
• Participation in any investigational drug or device study, systemic or ocular, within the past 3 months.
• Women who are pregnant or breast feeding.
• Women of child-bearing potential who are not using an effective form of birth control.
• Known serious allergies or hypersensitivity to the fluorescein dye used in angiography, or to the components of the MG-O-1002 formulation, or to topical anesthetics.
• In the opinion of the investigator, subject who is not suitable for or not likely be benefited from the study treatment.
• Part 2:

Sponsors & Collaborators

• Theratocular Biotek Co.: lead

Study Sites (6)

Rajavithi Hospital

Bangkok, Thailand

RECRUITING

Ramathibodi Hospital

Bangkok, Thailand

RECRUITING

Srinagarind Hospital

Khon Kaen, Thailand

RECRUITING

Metta Pracharak Hospital

Nakhon Pathom, Thailand

RECRUITING

Thammasat University Hospital

Pathum Thani, Thailand

RECRUITING

Naresuan University Hospital

Phitsanulok, Thailand

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Central Study Contacts

William Chen

CONTACT

2-2790-6566; william.chen@metagone.com.tw

Samjay Lin

CONTACT

2-2790-6566; samjay@metagone.com.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Part 1 - Open Label (24 Participants); Part 2 - Single-Blind to Participant (12 Participants)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: May 25, 2022
• Study Start: August 9, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: March 13, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TH (6)