Diabetic Macular EdemaPhase 1NCT06237777
A Clinical Study Evaluating the Safety, Tolerability and Initial Efficacy of SKG0106 Intravitreal Injection in Diabetic Macular Edema (DME) Patients
A Phase 1 study testing SKG0106 intravitreal injection dose level 1, 2 or 3 in people with Diabetic Macular Edema, run by Wang Min at 2 sites in China.
Trial summary
This is a clinical study to evaluate the safety, tolerability and initial efficacy of SKG0106 intravitreal injection in diabetic macular edema (DME) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- SKG0106 intravitreal injection dose level 1, 2 or 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesChina
- Study dates
- 27 Jun 2024to 28 Jul 2025
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent must be obtained prior to all assessments.
- Age ≥18 years at screening.
- Type 1 or type 2 diabetes mellitus at screening.
- Study eye criteria:
- Decreased visual acuity attributable primarily to DME.
- DME involves the macular center.
Who cannot join
- Active proliferative diabetic retinopathy in the study eye.
- Any current or previous ocular disease in the study eye other than DME that could interfere with macular evaluation or affect central vision at screening or baseline.
- Any active intraocular or periocular infection or active intraocular inflammation of the study eye at screening or baseline.
- History of idiopathic or autoimmune uveitis in the study eye at screening or baseline.
- Prior gene therapy in either eye.
- History of vitreoretinal surgery in the study eye.
Show all 10Show fewer
- Uncontrolled blood pressure at screening or baseline defined as systolic blood pressure (SBP) ≥160 mmHg or diastolic blood pressure (DBP) ≥100 mmHg.
- History of treated or untreated malignancy of any organ system within the past 5 years.
- Pregnant or lactating women.
- Women of reproductive age, defined as all women who are biologically capable of being pregnant, unless they use highly effective contraceptive methods between the time of study drug administration and 3 months after EOS (end of study).
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking Union Medical College Hospital
Beijing
Eye & ENT Hospital of Fudan University
Shanghai
About this study
Official title: An Open, Dose-escalation Clinical Study Evaluating the Safety, Tolerability and Initial Efficacy of SKG0106 Intravitreal Injection in Diabetic Macular Edema (DME) Patients in China
This is a clinical study to evaluate the safety, tolerability and initial efficacy of SKG0106 intravitreal injection in diabetic macular edema (DME) patients.
Read the detailed description
This is an open, dose-escalation clinical study to evaluate the safety, tolerability and initial efficacy of SKG0106 intravitreal injection in diabetic macular edema (DME) patients in China.
- Conditions
- Diabetic Macular Edema
- Being tested
- SKG0106 intravitreal injection dose level 1, 2 or 3
- Keywords
- DME
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKG0106 intravitreal injection dose level 1, 2 or 3Genetic
Also called SKG0106
SKG0106 is a recombinant adeno-associated virus (rAAV) vector-based in vivo gene therapeutic product.
| Study group | Role | What they receive |
|---|---|---|
| Dose-escalation | Experimental | SKG0106 one-time deliver Receives: Genetic: SKG0106 intravitreal injection dose level 1, 2 or 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type, severity, and incidence of ocular and systemic AEs
48 weeks
Measured: AEs: Adverse Events
Incidence of DLT
DLT (Dose-limiting Toxicity) is judged by assessing the following AEs such as:
- Severe visual acuity decline
- Endoophthalmitis by investigator
- Vitreous hemorrhage by investigator
Measured: 4 weeks
Secondary outcomes (3)
Mean change from baseline in BCVA
BCVA (Best Corrected Visual Acuity) of the study eye is examined by the Early Treatment of Diabetic Retinopathy Study (ETDRS) testing.
Measured: 48 weeks
Mean change from baseline in CST
CST (Central Subfield Thickness) is measured by Spectral domain optical coherence tomography (SD-OCT).
Measured: 48 weeks
Mean change from baseline in patient-reported outcome (VFQ-25) scale score
Both the total scale and subscale scores of the VFQ-25 (25-Item Visual Function Questionnaire) is ranging from 0 to 100, and higher scores mean a better outcome.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start27 Jun 2024
- Primary completion28 Jul 2025
- Study completion28 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wang Min
- Sponsor type
- University, hospital or other
- Collaborators
- Lanyue Biotech (Hangzhou) Co., Ltd.
- Responsible party
- Sponsor-investigator, Wang Min, Eye & ENT Hospital of Fudan University
- Investigators
- Min Wang, Doctor, Principal investigator, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237777
- Sponsor's protocol ID
- SKG0106-002
- Status last verified
- Aug 2026
- First submitted
- 11 Jan 2024
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Dose-escalation Clinical Study Evaluating the Safety, Tolerability and Initial Efficacy of SKG0106 Intravitreal Injection in Diabetic Macular Edema (DME) Patients in China
- ClinicalTrials.gov ID
- NCT06237777
- Acronym / sponsor ID
- SKG0106-002
- Conditions
- Diabetic Macular Edema
- Keywords
- DME
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Wang MinUniversity, hospital or other
- Collaborators
- Lanyue Biotech (Hangzhou) Co., Ltd.
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- 28 Jul 2025 (actual)
- Study completion
- 28 Jul 2025 (actual)
- First posted
- 1 Feb 2024 (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.
This is a clinical study to evaluate the safety, tolerability and initial efficacy of SKG0106 intravitreal injection in diabetic macular edema (DME) patients.
Detailed description
This is an open, dose-escalation clinical study to evaluate the safety, tolerability and initial efficacy of SKG0106 intravitreal injection in diabetic macular edema (DME) patients in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose-escalation | Experimental | Genetic: SKG0106 intravitreal injection dose level 1, 2 or 3SKG0106 one-time deliver |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent must be obtained prior to all assessments.
- Age ≥18 years at screening.
- Type 1 or type 2 diabetes mellitus at screening.
- Study eye criteria:
Key exclusion criteria (10 listed)
- Active proliferative diabetic retinopathy in the study eye.
- Any current or previous ocular disease in the study eye other than DME that could interfere with macular evaluation or affect central vision at screening or baseline.
- Any active intraocular or periocular infection or active intraocular inflammation of the study eye at screening or baseline.
- History of idiopathic or autoimmune uveitis in the study eye at screening or baseline.
- Prior gene therapy in either 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 |
|---|---|---|
| SKG0106 intravitreal injection dose level 1, 2 or 3Also: SKG0106SKG0106 is a recombinant adeno-associated virus (rAAV) vector-based in vivo gene therapeutic product. | Genetic | Dose-escalation |
Primary outcome
Type, severity, and incidence of ocular and systemic AEs
Time frame: AEs: Adverse Events
48 weeks
Incidence of DLT
Time frame: 4 weeks
DLT (Dose-limiting Toxicity) is judged by assessing the following AEs such as: * Severe visual acuity decline * Endoophthalmitis by investigator * Vitreous hemorrhage by investigator
3 secondary outcomes
Mean change from baseline in BCVA
Time frame: 48 weeks
Mean change from baseline in CST
Time frame: 48 weeks
Mean change from baseline in patient-reported outcome (VFQ-25) scale score
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
Related trials for Diabetic Macular Edema
Active, not recruitingObservational study
Long-Term Follow-up Study of ADVM-022 in DME (INFINITY-EXT)
Diabetic Macular Edema, Diabetic Retinopathy
RecruitingPhase 2
A Randomized, Phase 2 Study of Oral BGE-102 in Participants With Center-Involved Diabetic Macular Edema
Diabetic Macular Edema (DME)
Enrolling by invitationPhase 3
Suprachoroidal Bevacizumab Versus Intravitreal Bevacizumab in Diabetic Macular Edema
Diabetic Macular Edema (DME)
Not yet recruitingPhase 2
Study of CU06-1004 in Patients With Daibetic Macular Edema
DME, Diabetic Macular Edema
RecruitingPhase 3
A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-004)
Diabetic Retinopathy, Macular Edema
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.
Min Wang, Doctor principal investigator
Eye & ENT Hospital of Fudan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SKG0106 intravitreal injection dose level 1, 2 or 3 in people with Diabetic Macular Edema, run by Wang Min at 2 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 10 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: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type, severity, and incidence of ocular and systemic AEs (time frame: AEs: Adverse Events). The study lists 2 primary outcomes in all. 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 27 Aug 2026; AzTrials last refreshed its copy on 28 Oct 2026.