Age-Related Macular Degeneration
Conditions
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)
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.
Interventions
DRUGMG-O-1002
MG-O-1002 ophthalmic solution in one concentration (0.8%) ocular administration 3 drops in study eye
OTHERPlacebo
The placebo is 0.9% saline ocular administration 3 drops in study eye
Sponsors
Theratocular Biotek Co.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Part 1 - Open Label (24 Participants); Part 2 - Single-Blind to Participant (12 Participants)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Part 1: 1. Adults aged 45 years or older with a diagnosis of nAMD 2. 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) 3. Visual acuity from 20/25 to 20/200 in the study eye 4. Total lesion size (including neovascularization, blood) ≦12 disc areas (30.5 mm2) as assessed by Fluorescein Angiography. 5. Demonstrate the ability, or have a family member who is willing and able to, instill topical ocular drops in the study eye. 6. Ability to give written informed consent and comply with study procedures. Part 2: 1. Adults aged 45 years or older with a diagnosis of nAMD. 2. 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. 3. Demonstrate the ability, or have a family member who is willing and able to, instil topical ocular drops in the study eye. 4. Ability to give written informed consent and comply with study procedures.
Exclusion criteria
Part 1: 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. 2. 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. 3. Significant retinal serous pigment epithelial detachment (PED) involving the fovea. 4. 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. 5. 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. 6. Uncontrolled hypertension despite the use of antihypertensive medications. 7. Diagnosis of Type 1 or Type 2 diabetes. 8. Use of medications that in the opinion of the Investigator could interfere with study results. 9. Participation in any investigational drug or device study, systemic or ocular, within the past 3 months. 10. Women who are pregnant or breast feeding. 11. Women of child-bearing potential who are not using an effective form of birth control. 12. 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. 13. In the opinion of the investigator, subject who is not suitable for or not likely be benefited from the study treatment. Part 2: 1. More than 30 days between 3rd injection of Aflibercept and Visit 1. 2. Patients who have received 3 injections of Aflibercept within the last 3 months and need continued treatment in the fellow eye. 3. Significant retinal serous pigment epithelial detachment (PED), atrophy, or fibrosis/scar involving the fovea. 4. 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. 5. Active intraocular inflammation or uveitis or scleritis or episcleritis in the study eye or ocular or periocular infection in either eye. 6. Uncontrolled hypertension despite the use of antihypertensive medications. 7. Diagnosis of Type 1 or Type 2 diabetes. 8. Use of medications that in the opinion of the Investigator could interfere with study results. 9. Participation in any investigational drug or device study, systemic or ocular, within the past 3 months. 10. Women who are pregnant or breast feeding. 11. Women of child-bearing potential who are not using an effective form of birth control. 12. 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. 13. In the opinion of the investigator, subject who is not suitable for or not likely be benefited from the study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline in central macular thickness over 12 weeks. | up to 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Incidence and severity of ocular and systemic adverse events | 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 |
| Mean change from baseline in total area of Choroidal Neovascularization (CNV) over 12 weeks | up to 12 weeks |
Countries
Thailand
Contacts
Primary ContactWilliam Chen
Backup ContactSamjay Lin
Outcome results
None listed