Evaluating SKG0106 injection for diabetic macular edema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.