Tests 4D-150 eye injection against aflibercept in diabetic macular edema
Tests a single eye injection, 4D-150, against aflibercept in adults with diabetic macular edema.
Plain-language title generated from the registry record
Registry title: A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Key facts
- Where
- Beijing, Changchun, Changsha, Haerbin, Hangzhou, Jinan, Lanzhou, Nanchang, Shanghai, Taiyuan, Taizhou, Tianjin, Weifang, Wuhan, and Zhengzhou, ChinaSee the 18 sites
- Phase
- Phase 3
Where in China
- Beijing Tongren HospitalBeijing, ChinaNot yet recruiting
- The Second Hospital of Jilin UniversityChangchun, ChinaNot yet recruiting
- The Second Xiangya Hospital of Central South UniversityChangsha, ChinaNot yet recruiting
- The Second Affiliated Hospital of Harbin Medical UniversityHaerbin, ChinaNot yet recruiting
- Zhejiang Provincial People's HospitalHangzhou, ChinaNot yet recruiting
- Eye Hospital of Shandong First Medical UniversityJinan, ChinaNot yet recruiting
- Zhengzhou Second Peoples HospitalJinan, ChinaNot yet recruiting
- Lanzhou University Second HospitalLanzhou, ChinaNot yet recruiting
- Nanchang University Affiliated Eye HospitalNanchang, ChinaNot yet recruiting
- Fudan University Eye & ENT HospitalShanghai, ChinaNot yet recruiting
- Shanghai First People's HospitalShanghai, ChinaNot yet recruiting
- Shanxi Academy of Medical Sciences - Shanxi Bethune HospitalTaiyuan, ChinaNot yet recruiting
- Taizhou Hospital of Zhejiang ProvinceTaizhou, ChinaNot yet recruiting
- Tianjin Medical University Eye HospitalTianjin, ChinaNot yet recruiting
- Weifang Eye HospitalWeifang, ChinaNot yet recruiting
- Huazhong University of Science and Technology-Tongji Medical College-The Central Hospital of WuhanWuhan, ChinaNot yet recruiting
- Wuhan University - Renmin Hospital (Hubei General Hospital)Wuhan, ChinaNot yet recruiting
- Henan Eye Hospital, Henan Provincial People's HospitalZhengzhou, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- 4D Molecular Therapeutics
- Trial code
- NCT07867080
- Record updated
- 10 November 2026
- Original description
A Phase 3, Randomized, Double-Masked, Active-Controlled Trial to Evaluate the Safety, Efficacy, and Durability of a Single Intravitreal Injection of 4D-150 versus Aflibercept in Adults with Diabetic Macular Edema (4SIGHT)Read full original descriptionShow less
A Phase 3, Randomized, Double-Masked, Active-Controlled Trial to Evaluate the Efficacy, Safety, and Durability of a Single Intravitreal Injection of 4D-150 Versus Aflibercept in Adults With Diabetic Macular Edema (4SIGHT)
A Phase 3, Randomized, Double-Masked, Active-Controlled Trial to Evaluate the Safety, Efficacy, and Durability of a Single Intravitreal Injection of 4D-150 versus Aflibercept in Adults with Diabetic Macular Edema (4SIGHT)
Exclusion: Any prior concomitant treatment for DME; History of prior significant ocular surgery or treatment; Any prior investigational drug, agent, device, or gene therapy; Ocular Condition; Macular conditions other than DME; History of retinal detachment in the study eye; History or presence of active inflammation or infection in either eye; Uncontrolled glaucoma or intraocular hypertension; Ocular Treatments/Interventions:; History or presence of moderate Proliferative Diabetic Retinopathy or worse; History or presence of low Intraocular Pressure.
5.2 Inclusion Criteria; Individuals eligible to participate in the trial must meet the following inclusion criteria:; General Inclusion Criteria; Signed informed consent before any protocol-specified assessment is performed; Ability and willingness to comply with the protocol-specified procedures (including IVT injection) and visits, in the Investigator's judgment; ≥18 years of age at time of signing informed consent; Documented diagnosis of diabetes mellitus (Type 1 or Type 2); WOCBP must agree to use highly effective contraception from the time of informed consent, through duration of trial participation; Agree to use a barrier method (e.g., condom) during intercourse for 3 months after Day 1 to prevent fluid transmission; sexually active males should not father a child or donate sperm during this period Ocular Inclusion Criteria; Macular thickening secondary to DME involving the center of the fovea (confirmed by the Reading Center) in the study eye; Study eye amenable to IVT injection identified; Presence of intraretinal fluid and/or subretinal fluid secondary to DME; Decreased visual acuity attributable primarily to DME, as determined by the Investigator; Demonstrated clinical response to aflibercept and functional stability in the study eye.