Edison, NJNCT07158775Now EnrollingIRB Ready

Geographic Atrophy (GA) Secondary to Dry Age-related Macular Degeneration (AMD) Clinical Trial in Edison, NJ

Access cutting-edge geographic atrophy (ga) secondary to dry age-related macular degeneration (amd) treatment through this clinical trial at a research site in Edison. Study-provided care at no cost to qualified participants.

Sponsored by Bionic Sight LLC

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Expert Care in Edison

Access geographic atrophy (ga) secondary to dry age-related macular degeneration (amd) specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related geographic atrophy (ga) secondary to dry age-related macular degeneration (amd) treatment provided free

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Check if you qualify for this geographic atrophy (ga) secondary to dry age-related macular degeneration (amd) clinical trial in Edison, NJ

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Why Participate?

  • No-Cost Study Care

  • Local to Edison

    Convenient for NJ residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Edison site if eligible
  4. 4Begin participation

About This Geographic Atrophy (GA) Secondary to Dry Age-related Macular Degeneration (AMD) Study in Edison

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. This is a seamless Phase 1/2 study in up to 10 patients for Phase 1 and 30 patients Phase 2 in patients with GA secondary to dry AMD.

Sponsor: Bionic Sight LLC

Who Can Participate

Inclusion Criteria

General Inclusion Criteria
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 Inclusion Criteria
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 efficacy 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.

Exclusion Criteria

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 results. Ophthalmic Exclusion Criteria
\> 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).

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Edison?

Yes, this clinical trial (NCT07158775) has an active research site in Edison, NJ that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Geographic Atrophy (GA) Secondary to Dry Age-related Macular Degeneration (AMD) Treatment Options in Edison, NJ

If you're searching for geographic atrophy (ga) secondary to dry age-related macular degeneration (amd) treatment options in Edison, NJ, this clinical trial (NCT07158775) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Edison research site is actively enrolling participants for this clinical trial. You'll receive care from experienced geographic atrophy (ga) secondary to dry age-related macular degeneration (amd) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all geographic atrophy (ga) secondary to dry age-related macular degeneration (amd) clinical trials near you to find additional studies recruiting in your area.

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