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)

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

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)

Eligibility Criteria

Inclusion

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) asassessed by Fluorescein Angiography.
  5. Demonstrate the ability, or have a family member who is willing and able to, instilltopical ocular drops in the study eye.
  6. Ability to give written informed consent and comply with study procedures. Part 2:
  7. Adults aged 45 years or older with a diagnosis of nAMD.
  8. 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.
  9. Demonstrate the ability, or have a family member who is willing and able to, instiltopical ocular drops in the study eye.
  10. Ability to give written informed consent and comply with study procedures.

Exclusion

Exclusion Criteria: Part 1:

  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.
  2. 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.
  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 macularedema, 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: penetratingkeratoplasty 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 studyresults.
  9. Participation in any investigational drug or device study, systemic or ocular, withinthe 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 inangiography, or to the components of the MG-O-1002 formulation, or to topicalanesthetics.
  13. In the opinion of the investigator, subject who is not suitable for or not likely bebenefited from the study treatment. Part 2:
  14. More than 30 days between 3rd injection of Aflibercept and Visit 1.
  15. Patients who have received 3 injections of Aflibercept within the last 3 months andneed continued treatment in the fellow eye.
  16. Significant retinal serous pigment epithelial detachment (PED), atrophy, orfibrosis/scar involving the fovea.
  17. 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.
  18. Active intraocular inflammation or uveitis or scleritis or episcleritis in the studyeye or ocular or periocular infection in either eye.
  19. Uncontrolled hypertension despite the use of antihypertensive medications.
  20. Diagnosis of Type 1 or Type 2 diabetes.
  21. Use of medications that in the opinion of the Investigator could interfere with studyresults.
  22. Participation in any investigational drug or device study, systemic or ocular, withinthe past 3 months.
  23. Women who are pregnant or breast feeding.
  24. Women of child-bearing potential who are not using an effective form of birth control.
  25. Known serious allergies or hypersensitivity to the fluorescein dye used inangiography, or to the components of the MG-O-1002 formulation, or to topicalanesthetics.
  26. 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

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.

Connect with a study center

  • Rajavithi Hospital

    Bangkok,
    Thailand

    Active - Recruiting

  • Ramathibodi Hospital

    Bangkok,
    Thailand

    Active - Recruiting

  • Srinagarind Hospital

    Khon Kaen,
    Thailand

    Active - Recruiting

  • Metta Pracharak Hospital

    Nakhon Pathom,
    Thailand

    Active - Recruiting

  • Thammasat University Hospital

    Pathum Thani,
    Thailand

    Active - Recruiting

  • Naresuan University Hospital

    Phitsanulok,
    Thailand

    Active - Recruiting

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