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Clinical

What is a Clinical Trial?

A clinical trial is a research study conducted with volunteers to evaluate the safety & effectiveness of a new medical treatment or intervention. It involves carefully designed protocols and methodology to gather scientific evidence and assess the potential benefits and risks of the intervention. These trials play a crucial role in advancing medical knowledge and improving healthcare by testing new drugs, therapies, and medical devices before they can be approved for widespread use.

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Clinical Trials

Macular Telangiectasia (MacTel)

MacTel is a bilateral retinal disease that leads to a gradual loss of central vision. The disease causes photoreceptors to be lost in a well-defined area (Ellipsoid Zone) of the retina. As the disease progresses, patients experience blurring, distorted vision, trouble reading, and loss of central vision. Our Encapsulated Cell Therapy (ECT) Platform releases Ciliary Neurotrophic Factor (CNTF), a protein shown to protect against the progressive loss of photoreceptors.

There are no known pharmacological treatment options for MacTel today.

MacTel Phase 3 Clinical Trials

International Sites

Australia
France
Germany
United Kingdom

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MacTel Studies

Neurotech Pre-Approval Access
And/Or Single Patient Requests

Neurotech required conditions for consideration of Pre-Approval Access and Single Patient Requests

  1. The patient must have a serious or life-threatening disease or condition.
  2. There must be an unmet medical need, or alternative therapies are not available, or the patient must have exhausted all such alternative therapies.
  3. The patient is not eligible or cannot participate in a clinical trial. In assessing the eligibility of a patient for potential pre-approval access, preference will be given to clinical trials, then pre-approval access programs, and then single patient access.
  4. Adequate supply is available to support both clinical development activities and pre-approval access.
  5. Sufficient scientific evidence to demonstrate that the benefits of the investigational medicine outweigh the risks.
  6. Providing pre-approval access will not jeopardize the initiation, conduct, or completion of clinical investigations and the overall development program to support registration of the product.
  7. Pre-approval access must be permitted by, and run in accordance with, applicable laws.
  8. The treating physician making the request is licensed and qualified to administer the investigational medicine and agrees to comply with Neurotech requirements and local regulations governing preapproval access and to adhere to applicable laws and regulations.

Bilateral Implant and Extension Studies

Glaucoma

Glaucoma is a disease of the optic nerve, characterized by the selective loss of retinal ganglion cells and associated reduction in the visual field. When the nerve is damaged, visual information loses the medium by which it is transferred to the brain. Over time, vision is slowly lost. All currently approved glaucoma medications are directed toward lowering intraocular pressure. However, another potential approach is protection against retinal ganglion cell atrophy. The protective effect of CNTF on retinal ganglion cells in laser-induced ocular hypertensive models has been previously demonstrated. Neurotech Pharmaceuticals is investigating the CNTF-producing NT-501 device for treatment of glaucoma.