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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Age-Related Macular Degeneration
Lead sponsor: Metagone Biotech Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-25
Enrollment: 36
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean change from baseline in central macular thickness over 12 weeks.
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Mean change from baseline in Best-Corrected Visual Acuity over 12 weeks
timeFrame: up to 12 weeks
measure: Mean Change from baseline in Visual Field over 12 weeks
timeFrame: up to 12 weeks
measure: Mean change from baseline in total area of Choroidal Neovascularization (CNV) over 12 weeks
timeFrame: up to 12 weeks
measure: The number of patients needing rescue treatment within 12 weeks
timeFrame: up to 12 weeks
measure: The time to rescue treatment for needed patients within 12 weeks
timeFrame: up to 12 weeks
measure: Incidence and severity of ocular and systemic adverse events
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital
city: Nakhon Pathom
country: Thailand
facility: Metta Pracharak Hospital
city: Pathum Thani
country: Thailand
facility: Thammasat University Hospital
city: Phitsanulok
country: Thailand
facility: Naresuan University Hospital
Study officials:
References: