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Tests treatment safety and results for Neovascular Age-Related Macular Degeneration (nAMD)
Official title Efficacy and Safety of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD) (STELLAR)
ClinicalTrials.gov ID: NCT07317934
What this study is testing
What is LX102?
LX102 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for neovascular age-related macular degeneration (namd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase III, randomized, open-label, active-controlled study to evaluate the efficacy and safety of subretinal injection of LX102 in participants with neovascular age-related macular degeneration. The study will evaluate a single subretinal injection of LX102 compared to an active comparator.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 80
You may be able to join if
- Willing and able to provide written, signed informed consent for this study;
- Age ≥50 and ≤80 years old;
- active CNV secondary to nAMD in the study eye confirmed by FFA or OCT;
- The BCVA between 24 and 78 letters (inclusive) in the study eye at Screening;
- Demonstrated clinical response to aflibercept treatments in the study eye confirmed by the Reading Center;
You likely can't join if
- Any condition in the investigator's opinion that could limit VA improvement in the study eye.
- CNV or macular edema in the study eye secondary to any causes other than AMD
- Subfoveal fibrosis or atrophy in the study eye, as determined by CRC;
- History of retinal detachment in the study eye at any time;
- History of idiopathic or autoimmune uveitis in either eye;
- Advanced glaucoma in the study eye;
See the full eligibility criteria
- Willing and able to provide written, signed informed consent for this study;
- Age ≥50 and ≤80 years old;
- active CNV secondary to nAMD in the study eye confirmed by FFA or OCT;
- The BCVA between 24 and 78 letters (inclusive) in the study eye at Screening;
- Demonstrated clinical response to aflibercept treatments in the study eye confirmed by the Reading Center;
- No anti-VEGF therapy in study eye within 28 days before screening;
- Must be pseudophakic in the study eye (at least 4 weeks after cataract surgery).
- Any condition in the investigator's opinion that could limit VA improvement in the study eye.
- CNV or macular edema in the study eye secondary to any causes other than AMD
- Subfoveal fibrosis or atrophy in the study eye, as determined by CRC;
- History of retinal detachment in the study eye at any time;
- History of idiopathic or autoimmune uveitis in either eye;
- Advanced glaucoma in the study eye;
- History of vitrectomy surgery in the study eye;
- History of intraocular surgery within 1 month before screening in the study eye;
- History of ocular or systemic gene therapy;
- Recent myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Guangzhou, Guangdong, China
- Shantou, Guangdong, China
- Zhongshan, Guangdong, China
- Harbin, Heilongjiang, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Xuzhou, Jiangsu, China
- Changchun, Jilin, China
- Jinan, Shandong, China
- Qingdao, Shandong, China
- Shanghai, Shanghai Municipality, China
- Taiyuan, Shanxi, China
- Xi’an, Shanxi, China
- Chengdu, Sichuan, China
- Tianjin, Tianjin Municipality, China
- Hangzhou, Zhejiang, China
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Guangzhou, Guangdong, China; Shantou, Guangdong, China; Zhongshan, Guangdong, China and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.