Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Intravitreal (IV… (NCT06550011) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Intravitreal (IVT) Injection of ABI-110 (AAV2.N54-VEGF Trap) in Subjects With Neovascular (Wet) Age-Related Macular Degeneration (wAMD), Including Symptomatic Macular Polypoidal Choroidal Vasculopathy (PCV)
United States18 participantsStarted 2024-08-07
Plain-language summary
This will be a clinical study to assess initial safety and tolerability of IVT ABI-110 in patients diagnosed with wet macular degeneration (wAMD), including symptomatic macular PCV.
Who can participate
Age range50 Years – 89 Years
SexALL
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Inclusion criteria
✓. Must be willing and able to provide written, signed informed consent.
✓. Age: Subjects ≥ 50 and ≤ 89 years of age at the time of signing the informed consent
✓. Diagnosis of wAMD, including symptomatic macular PCV, confirmed by the Central Reading Center
✓. The macular neovascularization lesion must be confirmed as determined by the Central Reading Center based on SD-OCT imaging at screening.
✓. BCVA ≤ 20/25 and ≥ 20/250 (≤ 80L and ≥ 30L ETDRS letters)
✓. History of ≥ 2 anti-VEGF injections prior to trial entry with meaningful response to anti-VEGF and continued need for anti-VEGF treatment
✓. Response to anti-VEGF at trial entry
Exclusion criteria
✕. Prior gene therapy, either eye
✕. Any active ocular/intraocular infection or inflammation (e.g., blepharitis, infectious conjunctivitis, keratitis, scleritis, uveitis) or history of idiopathic or autoimmune-associated uveitis, either eye
✕. History of retinal disease other than wAMD or PCV, study eye
✕. Any condition preventing visual acuity improvement (e.g., fibrosis, atrophy, or retinal epithelial tear in the center of the fovea), study eye.
✕. History of (or active) retinal detachment, study eye
✕. Uncontrolled glaucoma (defined as IOP \> 25 mmHg despite treatment), study eye, or history of steroid-response ocular hypertension/glaucoma in either eye
✕. History of intravitreal therapy, (other than anti-VEGF therapy) such as intravitreal steroid injection or investigational product, in the 6 months prior to screening, study eye
✕. Any prior treatment with photodynamic therapy or laser photocoagulation, study eye