BridgeMD
Tests treatment safety and results for Geographic Atrophy (GA) Secondary to Dry Age-related...
Official title A Phase 1/2 Study to Evaluate the Safety and Efficacy of Intravitreal Administration of BS01 in Patients With Geographic Atrophy Secondary to Dry AMD
ClinicalTrials.gov ID: NCT07158775
What this study is testing
What is BS01?
BS01 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for geographic atrophy (ga) secondary to dry age-related macular degeneration (amd).
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 1/2 study, multi-center, dose-escalation interventional study of BS01 in subjects with GA secondary to dry AMD. Part 1 is an open label dose-escalation study; Part 2 is a dose-expansion study with dose(s) selected from Part 1 based on a benefit/risk assessment, and an untreated (sham injection) group to allow for a controlled comparison of efficacy and safety.
- Phase 2: a mid-size study of how well it works
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 85
You may be able to join if
- General 1. Signed informed consent obtained before screening.
- Men or women between 50 and 85 years of age inclusive at the time of signing the informed consent. Ophthalmic 1. Geographic atrophy with some macula...
- Total GA area ≥ 5 and ≤ 17.5 mm2 (2 and 7 disk areas respectively), based on Heidelberg Region Finder or equivalent automated software.
- If GA is multifocal, at least one focal lesion should measure ≥ 1.25 mm2 (0.5 disk area) to ensure measurable focal effects for how well it works...
- Composite lesion encompassing confluent GA regions with total area meeting thresholds given in 2 above.
You likely can't join if
- General Exclusion Criteria
- Previous therapeutic radiation in the region of the SE.
- Previous treatment with any ocular or systemic gene transfer product.
- Any treatment with an investigational agent in the past 60 days for any condition.
- Women who are pregnant or nursing.
- Known hypersensitivity to topical ocular anesthetics or diagnostic drops to be used during the study.
See the full eligibility criteria
- General 1. Signed informed consent obtained before screening.
- Men or women between 50 and 85 years of age inclusive at the time of signing the informed consent. Ophthalmic 1. Geographic atrophy with some macula foveal involvement secondary to dry AMD.
- Total GA area ≥ 5 and ≤ 17.5 mm2 (2 and 7 disk areas respectively), based on Heidelberg Region Finder or equivalent automated software.
- If GA is multifocal, at least one focal lesion should measure ≥ 1.25 mm2 (0.5 disk area) to ensure measurable focal effects for how well it works evaluation.
- Composite lesion encompassing confluent GA regions with total area meeting thresholds given in 2 above.
- GA in part within 1200 microns from the foveal center.
- The atrophic lesion must be able to be photographed in its entirety.
- BCVA between 20/50 to 20/400, inclusive, using letter score per EDTRS chart.
- 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).
- Central fixation.
- General Exclusion Criteria
- Previous therapeutic radiation in the region of the SE.
- Previous treatment with any ocular or systemic gene transfer product.
- Any treatment with an investigational agent in the past 60 days for any condition.
- Women who are pregnant or nursing.
- Known hypersensitivity to topical ocular anesthetics or diagnostic drops to be used during the study.
- 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...
- \> 30% difference of BCVA using EDTRS in two baseline visual acuity assessments with at least 14 days apart during screening.
- Any intraocular surgery or thermal laser within 3 months of study entry. Any prior thermal laser in the macular region, regardless of indication.
- Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past 12 weeks.
- History of any of the following procedures: Posterior vitrectomy, filtering surgery (e.g., trabeculectomy), glaucoma drainage device, corneal transplant, or retinal detachment.
- Any sign of diabetic retinopathy in either eye.
- Intraocular pressure (IOP) \> 25 mmHg in either eye.
- Completely atrophic centrally located lesions based on ellipsoid zone (EZ) loss in spectraldomain optical coherence tomography (SD-OCT).
The study team makes the final eligibility decision.
Where it's taking place
- Edison, New Jersey, United States
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 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edison, New Jersey, United States. 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.