Evaluating SKG0106 injection for diabetic macular edema
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 study is testing a new injection called SKG0106 to see if it can help improve vision in people with diabetic macular edema.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Locations | 2 sites (Beijing and 1 other locations) |
| Trial ID | NCT06237777 on ClinicalTrials.gov |
What this trial studies
This clinical study is designed to assess the safety, tolerability, and initial efficacy of SKG0106, an intravitreal injection, in patients suffering from diabetic macular edema (DME). It is an open, dose-escalation study conducted in China, where participants will receive varying doses of the treatment. The study aims to determine how well the injection works in improving visual acuity affected by DME.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with type 1 or type 2 diabetes and decreased visual acuity due to DME.
Not a fit: Patients with active proliferative diabetic retinopathy or other ocular diseases that could interfere with the study will not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve vision for patients with diabetic macular edema.
How similar studies have performed: While this approach is novel, similar studies targeting diabetic macular edema have shown promising results in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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).
Where this trial is running
Beijing and 1 other locations
- Peking Union Medical College Hospital — Beijing, China (Recruiting)
- Eye & ENT Hospital of Fudan University — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Min Wang, Doctor — Eye & ENT Hospital of Fudan University
- Study coordinator: Min Wang, Doctor
- Email: ykmarkwang@163.com
- Phone: +86 13816630287
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.