Last updated: March 11, 2024
Sponsor: Theratocular Biotek Co.
Overall Status: Active - Recruiting
Phase
2
Condition
Macular Degeneration
Aging
Geographic Atrophy
Treatment
Placebo
MG-O-1002
Clinical Study ID
NCT05390840
TO-02C201
Ages > 45 All Genders
Study Summary
Eligibility Criteria
Inclusion
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) asassessed by Fluorescein Angiography.
- Demonstrate the ability, or have a family member who is willing and able to, instilltopical 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 thepreceding 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, instiltopical ocular drops in the study eye.
- Ability to give written informed consent and comply with study procedures.
Exclusion
Exclusion Criteria: Part 1:
- Prior use within the last 2 months, or a high possibility of requiring treatment withanti-VEGF therapy (except the study drug) in both eyes during the study.
- Abnormal regions identified by Fundus Autofluorescence (FAF) and Optical CoherenceTomography (OCT) involving the center of the fovea are caused by retinal pigmentepithelium (RPE) atrophy, RPE tear, photoreceptor attenuation, or fibrosis/scartissue.
- Significant retinal serous pigment epithelial detachment (PED) involving the fovea.
- History of, or current clinical evidence in the study eye of aphakia, diabetic macularedema, 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: penetratingkeratoplasty 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 studyresults.
- Participation in any investigational drug or device study, systemic or ocular, withinthe 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 inangiography, or to the components of the MG-O-1002 formulation, or to topicalanesthetics.
- In the opinion of the investigator, subject who is not suitable for or not likely bebenefited 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 andneed continued treatment in the fellow eye.
- Significant retinal serous pigment epithelial detachment (PED), atrophy, orfibrosis/scar involving the fovea.
- History or evidence of the following surgeries in the study eye: penetratingkeratoplasty or vitrectomy; corneal transplant; corneal or intraocular surgery within 3 months of Screening.
- Active intraocular inflammation or uveitis or scleritis or episcleritis in the studyeye 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 studyresults.
- Participation in any investigational drug or device study, systemic or ocular, withinthe 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 inangiography, or to the components of the MG-O-1002 formulation, or to topicalanesthetics.
- In the opinion of the investigator, subject who is not suitable for or not likely bebenefited from the study treatment.
Study Design
Total Participants: 36
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
August 09, 2022
Estimated Completion Date:
March 31, 2024
Study Description
Connect with a study center
Rajavithi Hospital
Bangkok,
ThailandActive - Recruiting
Ramathibodi Hospital
Bangkok,
ThailandActive - Recruiting
Srinagarind Hospital
Khon Kaen,
ThailandActive - Recruiting
Metta Pracharak Hospital
Nakhon Pathom,
ThailandActive - Recruiting
Thammasat University Hospital
Pathum Thani,
ThailandActive - Recruiting
Naresuan University Hospital
Phitsanulok,
ThailandActive - Recruiting
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