Intravitreal BS01 for geographic atrophy from dry AMD

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 is a seamless Phase 1/2, multi-center, dose-escalation and expansion trial of intravitreal BS01 in patients with geographic atrophy secondary to dry AMD. Part 1 is an open-label dose-escalation cohort enrolling up to 10 patients to define safety and an appropriate dose, and Part 2 is a dose-expansion cohort of up to 30 patients that includes a selected BS01 dose and an untreated (sham injection) control group for controlled comparison of safety and efficacy. Key ophthalmic entry criteria include GA with some foveal involvement, total lesion area between 5 and 17.5 mm2, at least one focal lesion ≥1.25 mm2 if multifocal, and BCVA between 20/50 and 20/400. Participants will receive intravitreal injections or sham procedures with scheduled imaging and visual acuity follow-up to monitor lesion size, function, and adverse events.

Why it matters

Who can join: the full rules

Inclusion Criteria:

General Inclusion Criteria

1. Signed informed consent obtained before screening.
2. Men or women between 50 and 85 years of age inclusive at the time of signing the informed consent.

Ophthalmic Inclusion Criteria

1. Geographic atrophy with some macula foveal involvement secondary to dry AMD.
2. Total GA area ≥ 5 and ≤ 17.5 mm2 (2 and 7 disk areas respectively), based on Heidelberg Region Finder or equivalent automated software.
3. If GA is multifocal, at least one focal lesion should measure ≥ 1.25 mm2 (0.5 disk area) to ensure measurable focal effects for efficacy evaluation.
4. Composite lesion encompassing confluent GA regions with total area meeting thresholds given in 2 above.
5. GA in part within 1200 microns from the foveal center.
6. The atrophic lesion must be able to be photographed in its entirety.
7. BCVA between 20/50 to 20/400, inclusive, using letter score per EDTRS chart.
8. Clear ocular media and adequate pupillary dilatation in both eyes to allow for all imaging procedures, including good quality stereoscopic fundus photography and fundus autofluorescence (FAF).
9. Central fixation.

Exclusion Criteria:

General Exclusion Criteria

1. Previous therapeutic radiation in the region of the SE.
2. Previous treatment with any ocular or systemic gene transfer product.
3. Any treatment with an investigational agent in the past 60 days for any condition.
4. Women who are pregnant or nursing.
5. Known hypersensitivity to topical ocular anesthetics or diagnostic drops to be used during the study.
6. Any other medical condition, which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromises patient safety, or interferes with the interpretation of the study results.

Ophthalmic Exclusion Criteria

1. \> 30% difference of BCVA using EDTRS in two baseline visual acuity assessments with at least 14 days apart during screening.
2. Any intraocular surgery or thermal laser within 3 months of study entry. Any prior thermal laser in the macular region, regardless of indication.
3. Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past 12 weeks.
4. History of any of the following procedures: Posterior vitrectomy, filtering surgery (e.g., trabeculectomy), glaucoma drainage device, corneal transplant, or retinal detachment.
5. Any sign of diabetic retinopathy in either eye.
6. Intraocular pressure (IOP) \> 25 mmHg in either eye.
7. Completely atrophic centrally located lesions based on ellipsoid zone (EZ) loss in spectraldomain optical coherence tomography (SD-OCT).

Where it's running

• NJ Retina
  Edison, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Sheila Nirenberg, PhD+
• Email: snsheilan@gmail.com
• Phone: 1+9178425027

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Short-term progression of geographic atrophy in people with age-related macular degeneration

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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.