Neovascular Age-related Macular DegenerationPhase 1/2NCT06183814
A Study of EXG102-031 in Participants With wAMD
A Phase 1/2 study testing EXG102-031 in people with Neovascular Age-related Macular Degeneration, run by Guangzhou Jiayin Biotech Ltd at 8 sites in China.
Trial summary
In neovascular (wet) age-related macular degeneration (wAMD), the macula, or the part of the eye that provides the clear, detailed central vision, is being affected by abnormal blood vessel growth and leakage. This leakage affects the vision over time and can lead to severe blurriness or blinding. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- EXG102-031
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 8 sitesChina
- Study dates
- 12 Oct 2023to 31 Dec 2025
- Phase
- Phase 1/2
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age ≥ 50 years of age;
- Diagnosis of wAMD and current active lesion in the study eye at Screening;
- An ETDRS BCVA letter scores between 73 and 9 letters in the study eye;
- Response to anti-VEGF treatment within 6 months prior to screening or at the time of screening introduction;
- The study eye must be a Intraocular lens eye(post-cataract surgery status) and be at least 1 month post IOL implantation at enrollment;
- Voluntarily agree to participate in the clinical trial, understand the trial procedures, and be capable of signing the informed consent form before screening.
Who cannot join
- Presence of any ocular disease or history of disease in the study eye other than wAMD that may affect central visual acuity and/or macular detection;
- Presence in the study eye of CNV or macular pathology pathography due to causes other than wAMD;
- The study eye has severe and irreversible retinal structural damage involving the fovea (such as retinal pigment epithelial (RPE) atrophy, retinal fibrosis, laser scars, dense hard exudation); Or other retinal damage in the target eye that, in the opinion of the investigator, may impede visual improvement after resolution of macular edema ;
- Subretinal hemorrhage accumulating the central fovea of the study eye, with an area of hemorrhage ≥ 4 optic disc diameters;
- Presence of advanced glaucoma or uncontrolled ocular hypertension in the study eye;
- Prior receipt of any ocular or systemic gene therapy agent.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites, 8 recruiting
- Not yet recruiting
Beijing Hospital
Beijing, Beijing Municipality, 100000
Haijuan Zhao
Xiaobing Yu, PhD
- Not yet recruiting
Beijing Tongren Hospital,Cmu
Beijing, Beijing Municipality, 100000
Yuyang Dai
Wenbin Wei, PhD
- Recruiting
Peking University People'S Hospital
Beijing, Beijing Municipality, 100000
Lijue Wang
Mingwei Zhao, PhD
- Not yet recruiting
The Southwest Hospital of Amu
Chongqing, Chongqing Municipality
Linli Xie
Yong Liu, PhD
- Not yet recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
Zourong Ruan
Ke Yao, PhD
- Not yet recruiting
Jiangsu Provinve Hospital
Nanjing, Jiangsu
Yi Chai
Qinghuai Liu, PhD
- Not yet recruiting
Eye Hospital,WMU
Wenzhou, Zhejiang
Zhishu Bao
Jia Qu, PhD
- Recruiting
Central theater General Hospital
Wuhai, Hubei
Airong Yu
Yanping Song, PhD
About this study
Official title: An Open-label, Dose-escalation Phase I/IIa Study to Evaluate the Safety and Efficacy of EXG102-031 Intraocular Injection in Participants With Neovascular Age-related Macular Degeneration（wAMD）
In neovascular (wet) age-related macular degeneration (wAMD), the macula, or the part of the eye that provides the clear, detailed central vision, is being affected by abnormal blood vessel growth and leakage. This leakage affects the vision over time and can lead to severe blurriness or blinding. EXG102-031 was made to block the extra vessel formation which would lead to less leakage affecting the vision. Before EXG102-031 can be tested for its efficacy (if it makes vision better), it must be tested to see if it is safely tolerated to confirm it can continue to be studied in more patients with wAMD.
Read the detailed description
Age-related macular degeneration (AMD) is a major cause of blindness and visual impairment in older adults. The wet form of AMD, also called neovascular AMD (nAMD) usually causes faster vision loss than the dry form. The most common current treatments of nAMD are products that inhibit vascular endothelial growth factor (VEGF) (including ranibizumab (LUCENTIS®, Genentech) and aflibercept (EYLEA®, Regeneron) and are delivered by intravitreal injections at 4 to 16 week intervals and continued indefinitely. This Open-label, Dose-escalation Phase I/IIa Study is designed to evaluate the safety and efficacy of EXG102-031 intraocular Injection in participants with wet(Neovascular) Age-related Macular Degeneration（wAMD）.
- Being tested
- EXG102-031
- Keywords
- Wet Age-related Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXG102-031Biological
EXG102-031 is a recombinant adeno-associated virus (rAAV) expressing an angiopoietin domain and VEGF receptor (ABD-VEGFR) fusion protein. EXG102-031 will be administered by subretinal injection.
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation-Cohort 1 | Experimental | Genetic : EXG102-031 Receives: Biological: EXG102-031 |
| Dose escalation-Cohort 2 | Experimental | Genetic : EXG102-031 Receives: Biological: EXG102-031 |
| Dose escalation-Cohort 3 | Experimental | Genetic : EXG102-031 Receives: Biological: EXG102-031 |
| Dose escalation-Cohort 4 | Experimental | Genetic : EXG102-031 Receives: Biological: EXG102-031 |
| Dose escalation-Cohort 5 | Experimental | Genetic : EXG102-031 Receives: Biological: EXG102-031 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (Participants With Ocular and Non-ocular AEs (Adverse Events) and SAEs (Serious Adverse Events)
incidence of ocular and non-ocular AEs and SAEs
Measured: 24 weeks following EXG102-031 administration
Secondary outcomes (4)
Safety (Participants With Ocular and Non-ocular AEs (Adverse Events) and SAEs (Serious Adverse Events)
incidence of ocular and non-ocular AEs and SAEs
Measured: 52 weeks following EXG102-031 administration
Change From Baseline in BCVA (Best Corrected Visual Acuity)
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision.
Measured: 52 weeks following EXG102-031 administration
Change From Baseline in CRT (Central Retinal Thickness)
Retinal fluid status of the study eye was evaluated using spectral domain OCT (Optical Coherence Tomography). A decrease in value indicates a decrease in fluid
Measured: 52 weeks following EXG102-031 administration
Supplemental Injections (Annualized Rate of Supplemental Injections)
The number of supplemental anti-VEGF injections given after EXG102-031 was administered.
Measured: 52 weeks following EXG102-031 administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start12 Oct 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose escalation
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Jiayin Biotech Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mingwei Zhao, PhD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183814
- Sponsor's protocol ID
- EXG102-031-111
- Status last verified
- Jan 2024
- First submitted
- 4 Dec 2023
- Last updated
- 9 Jan 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 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Dose-escalation Phase I/IIa Study to Evaluate the Safety and Efficacy of EXG102-031 Intraocular Injection in Participants With Neovascular Age-related Macular Degeneration（wAMD）
- ClinicalTrials.gov ID
- NCT06183814
- Acronym / sponsor ID
- EXG102-031-111
- Keywords
- Wet Age-related Macular Degeneration
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Guangzhou Jiayin Biotech LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Dec 2023 (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.
In neovascular (wet) age-related macular degeneration (wAMD), the macula, or the part of the eye that provides the clear, detailed central vision, is being affected by abnormal blood vessel growth and leakage. This leakage affects the vision over time and can lead to severe blurriness or blinding. EXG102-031 was made to block the extra vessel formation which would lead to less leakage affecting the vision. Before EXG102-031 can be tested for its efficacy (if it makes vision better), it must be tested to see if it is safely tolerated to confirm it can continue to be studied in more patients with wAMD.
Detailed description
Age-related macular degeneration (AMD) is a major cause of blindness and visual impairment in older adults. The wet form of AMD, also called neovascular AMD (nAMD) usually causes faster vision loss than the dry form. The most common current treatments of nAMD are products that inhibit vascular endothelial growth factor (VEGF) (including ranibizumab (LUCENTIS®, Genentech) and aflibercept (EYLEA®, Regeneron) and are delivered by intravitreal injections at 4 to 16 week intervals and continued indefinitely. This Open-label, Dose-escalation Phase I/IIa Study is designed to evaluate the safety and efficacy of EXG102-031 intraocular Injection in participants with wet(Neovascular) Age-related Macular Degeneration（wAMD）.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Dose escalation
| Arm | Type | Receives |
|---|---|---|
| Dose escalation-Cohort 1 | Experimental | Biological: EXG102-031Genetic : EXG102-031 |
| Dose escalation-Cohort 2 | Experimental | Biological: EXG102-031Genetic : EXG102-031 |
| Dose escalation-Cohort 3 | Experimental | Biological: EXG102-031Genetic : EXG102-031 |
| Dose escalation-Cohort 4 | Experimental | Biological: EXG102-031Genetic : EXG102-031 |
| Dose escalation-Cohort 5 | Experimental | Biological: EXG102-031Genetic : EXG102-031 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, age ≥ 50 years of age;
- Diagnosis of wAMD and current active lesion in the study eye at Screening;
- An ETDRS BCVA letter scores between 73 and 9 letters in the study eye;
- Response to anti-VEGF treatment within 6 months prior to screening or at the time of screening introduction;
- The study eye must be a Intraocular lens eye(post-cataract surgery status) and be at least 1 month post IOL implantation at enrollment;
Key exclusion criteria (6 listed)
- Presence of any ocular disease or history of disease in the study eye other than wAMD that may affect central visual acuity and/or macular detection;
- Presence in the study eye of CNV or macular pathology pathography due to causes other than wAMD;
- The study eye has severe and irreversible retinal structural damage involving the fovea (such as retinal pigment epithelial (RPE) atrophy, retinal fibrosis, laser scars, dense hard exudation); Or other retinal damage in the target eye that, in the opinion of the investigator, may impede visual improvement after resolution of macular edema ;
- Subretinal hemorrhage accumulating the central fovea of the study eye, with an area of hemorrhage ≥ 4 optic disc diameters;
- Presence of advanced glaucoma or uncontrolled ocular hypertension in the study eye;
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 |
|---|---|---|
| EXG102-031EXG102-031 is a recombinant adeno-associated virus (rAAV) expressing an angiopoietin domain and VEGF receptor (ABD-VEGFR) fusion protein. EXG102-031 will be administered by subretinal injection. | Biological | Dose escalation-Cohort 1, Dose escalation-Cohort 2, Dose escalation-Cohort 3, Dose escalation-Cohort 4, Dose escalation-Cohort 5 |
Primary outcome
Safety (Participants With Ocular and Non-ocular AEs (Adverse Events) and SAEs (Serious Adverse Events)
Time frame: 24 weeks following EXG102-031 administration
incidence of ocular and non-ocular AEs and SAEs
4 secondary outcomes
Safety (Participants With Ocular and Non-ocular AEs (Adverse Events) and SAEs (Serious Adverse Events)
Time frame: 52 weeks following EXG102-031 administration
Change From Baseline in BCVA (Best Corrected Visual Acuity)
Time frame: 52 weeks following EXG102-031 administration
Change From Baseline in CRT (Central Retinal Thickness)
Time frame: 52 weeks following EXG102-031 administration
Supplemental Injections (Annualized Rate of Supplemental Injections)
Time frame: 52 weeks following EXG102-031 administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 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.
Mingwei Zhao, PhD principal investigator
Peking University People's Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EXG102-031 in people with Neovascular Age-related Macular Degeneration, run by Guangzhou Jiayin Biotech Ltd at 8 sites in China.
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 6 inclusion and 6 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 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Sara Yang (+86 13957164092, sarayang@exegenesisbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (Participants With Ocular and Non-ocular AEs (Adverse Events) and SAEs (Serious Adverse Events) (time frame: 24 weeks following EXG102-031 administration). 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 9 Jan 2024.