Age-Related Macular DegenerationPhase 2NCT05390840
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)
A Phase 2 study testing MG-O-1002 in people with Age-Related Macular Degeneration, run by Theratocular Biotek Co. at 6 sites in Thailand.
Trial 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) Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- MG-O-1002
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 6 sitesThailand
- Study dates
- 9 Aug 2022to Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Thailand6 sites, 6 recruiting
- Recruiting
Rajavithi Hospital
Bangkok
- Recruiting
Ramathibodi Hospital
Bangkok
- Recruiting
Srinagarind Hospital
Khon Kaen
- Recruiting
Metta Pracharak Hospital
Nakhon Pathom
- Recruiting
Thammasat University Hospital
Pathum Thani
- Recruiting
Naresuan University Hospital
Phitsanulok
About this study
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)
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)
Read the 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.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- MG-O-1002, Placebo
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MG-O-1002Drug
MG-O-1002 ophthalmic solution in one concentration (0.8%) ocular administration 3 drops in study eye
PlaceboOther
The placebo is 0.9% saline ocular administration 3 drops in study eye
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (MG-O-1002) | Experimental | Drug: MG-O-1002; Dose level: 0.8%; Dosage form: ophthalmic solution; Route of administration: topical ocular Receives: Drug: MG-O-1002 |
| Part 2 (MG-O-1002 or Placebo) | Placebo comparator | 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 Receives: Drug: MG-O-1002; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in central macular thickness over 12 weeks.
Measured: up to 12 weeks
Secondary outcomes (6)
Mean change from baseline in Best-Corrected Visual Acuity over 12 weeks
Measured: up to 12 weeks
Mean Change from baseline in Visual Field over 12 weeks
Measured: up to 12 weeks
Mean change from baseline in total area of Choroidal Neovascularization (CNV) over 12 weeks
Measured: up to 12 weeks
The number of patients needing rescue treatment within 12 weeks
Measured: up to 12 weeks
The time to rescue treatment for needed patients within 12 weeks
Measured: up to 12 weeks
Incidence and severity of ocular and systemic adverse events
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start9 Aug 2022
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Theratocular Biotek Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390840
- Sponsor's protocol ID
- TO-02C201
- Status last verified
- Oct 2023
- First submitted
- 20 May 2022
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05390840
- Acronym / sponsor ID
- TO-02C201
- Conditions
- Age-Related Macular Degeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Theratocular Biotek Co.Industry (pharma, biotech, devices)
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 (MG-O-1002) | Experimental | Drug: MG-O-1002Drug: MG-O-1002; Dose level: 0.8%; Dosage form: ophthalmic solution; Route of administration: topical ocular |
| Part 2 (MG-O-1002 or Placebo) | Placebo comparator | Drug: MG-O-1002, Other: PlaceboArm 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 |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MG-O-1002MG-O-1002 ophthalmic solution in one concentration (0.8%) ocular administration 3 drops in study eye | Drug | Part 1 (MG-O-1002), Part 2 (MG-O-1002 or Placebo) |
| PlaceboThe placebo is 0.9% saline ocular administration 3 drops in study eye | Other | Part 2 (MG-O-1002 or Placebo) |
Primary outcome
Mean change from baseline in central macular thickness over 12 weeks.
Time frame: up to 12 weeks
6 secondary outcomes
Mean change from baseline in Best-Corrected Visual Acuity over 12 weeks
Time frame: up to 12 weeks
Mean Change from baseline in Visual Field over 12 weeks
Time frame: up to 12 weeks
Mean change from baseline in total area of Choroidal Neovascularization (CNV) over 12 weeks
Time frame: up to 12 weeks
The number of patients needing rescue treatment within 12 weeks
Time frame: up to 12 weeks
The time to rescue treatment for needed patients within 12 weeks
Time frame: up to 12 weeks
Incidence and severity of ocular and systemic adverse events
Time frame: up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MG-O-1002 in people with Age-Related Macular Degeneration, run by Theratocular Biotek Co. at 6 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact William Chen (2-2790-6566 ext. +886, william.chen@metagone.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in central macular thickness over 12 weeks. (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.