- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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)
March 11, 2024 updated by: Theratocular Biotek Co.
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)
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)
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
36
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: William Chen
- Phone Number: +886 2-2790-6566
- Email: william.chen@metagone.com.tw
Study Contact Backup
- Name: Samjay Lin
- Phone Number: +886 2-2790-6566
- Email: samjay@metagone.com.tw
Study Locations
-
-
-
Bangkok, Thailand
- Recruiting
- Rajavithi Hospital
-
Bangkok, Thailand
- Recruiting
- Ramathibodi Hospital
-
Khon Kaen, Thailand
- Recruiting
- Srinagarind Hospital
-
Nakhon Pathom, Thailand
- Recruiting
- Metta Pracharak Hospital
-
Pathum Thani, Thailand
- Recruiting
- Thammasat University Hospital
-
Phitsanulok, Thailand
- Recruiting
- Naresuan University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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:
- More than 30 days between 3rd injection of Aflibercept and Visit 1.
- Patients who have received 3 injections of Aflibercept within the last 3 months and need continued treatment in the fellow eye.
- Significant retinal serous pigment epithelial detachment (PED), atrophy, or fibrosis/scar involving the fovea.
- 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.
- Active intraocular inflammation or uveitis or scleritis or episcleritis in the study eye or ocular or periocular infection in either eye.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part 1 (MG-O-1002)
Drug: MG-O-1002; Dose level: 0.8%; Dosage form: ophthalmic solution; Route of administration: topical ocular
|
MG-O-1002 ophthalmic solution in one concentration (0.8%) ocular administration 3 drops in study eye
|
Placebo Comparator: Part 2 (MG-O-1002 or Placebo)
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 |
MG-O-1002 ophthalmic solution in one concentration (0.8%) ocular administration 3 drops in study eye
The placebo is 0.9% saline ocular administration 3 drops in study eye
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean change from baseline in central macular thickness over 12 weeks.
Time Frame: up to 12 weeks
|
up to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean change from baseline in Best-Corrected Visual Acuity over 12 weeks
Time Frame: up to 12 weeks
|
up to 12 weeks
|
Mean Change from baseline in Visual Field over 12 weeks
Time Frame: up to 12 weeks
|
up to 12 weeks
|
Mean change from baseline in total area of Choroidal Neovascularization (CNV) over 12 weeks
Time Frame: up to 12 weeks
|
up to 12 weeks
|
The number of patients needing rescue treatment within 12 weeks
Time Frame: up to 12 weeks
|
up to 12 weeks
|
The time to rescue treatment for needed patients within 12 weeks
Time Frame: up to 12 weeks
|
up to 12 weeks
|
Incidence and severity of ocular and systemic adverse events
Time Frame: up to 12 weeks
|
up to 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 9, 2022
Primary Completion (Estimated)
March 1, 2024
Study Completion (Estimated)
March 1, 2024
Study Registration Dates
First Submitted
May 20, 2022
First Submitted That Met QC Criteria
May 20, 2022
First Posted (Actual)
May 25, 2022
Study Record Updates
Last Update Posted (Actual)
March 13, 2024
Last Update Submitted That Met QC Criteria
March 11, 2024
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TO-02C201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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