Trial Search Results

EXPLORE: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005

The purpose of this clinical study is to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with geographic atrophy secondary to age-related macular degeneration (AMD).

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Gyroscope Therapeutics Limited

Collaborator: Novartis Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Drug: GT005; Low Dose
  • Drug: GT005; High Dose

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   1. Able and willing to give written informed consent

   2. Age ≥55 years

   3. Have a clinical diagnosis of GA secondary to AMD in the study eye, as determined by
   the Investigator, and a diagnosis of AMD in the contralateral eye

   4. GA lesion(s) within an acceptable size on FAF, in the study eye

   5. The GA lesion(s) in the study eye must reside completely within the FAF image

   6. Up to 25% of the enrolled study population are permitted to have CNV in the fellow eye

   7. Have a BCVA of 24 letters (6/95 and 20/320 Snellen acuity equivalent) or better, using
   ETDRS charts, in the study eye

   8. Have a rare genetic variant of the CFI gene, defined as a minor allele frequency of
   <1%

   9. Able to attend all study visits and complete the study procedures

10. Women of child-bearing potential must have a negative pregnancy test within 2 weeks
   prior to randomisation (not required for women who are postmenopausal or surgically
   sterilised)

Exclusion Criteria:

   1. Have a history, or evidence, of CNV in the study eye

   2. Presence of moderate/severe or worse non-proliferative diabetic retinopathy in the
   study eye

   3. Have history of vitrectomy, sub-macular surgery, or macular photocoagulation in the
   study eye

   4. History of intraocular surgery in the study eye within 12 weeks prior to Screening.

   5. Have clinically significant cataract that may require surgery during the study period
   in the study eye.

   6. Presence of moderate to severe glaucomatous optic neuropathy in the study eye,
   uncontrolled intraocular pressure (IOP) despite the use of more than two topical
   agents, or a history of glaucoma-filtering or valve surgery

   7. Axial myopia of greater than -8 diopters in the study eye

   8. Have any other significant ocular or non-ocular medical or psychiatric condition
   which, in the opinion of the Investigator, may either put the subject at risk or may
   influence the results of the study

   9. Have a contraindication to the specified protocol corticosteroid regimen

10. Have received any investigational product for the treatment of GA within the past 6
   months, or 5 half-lives (whichever is longer) other than nutritional supplements such
   as the age-related eye disease study (AREDS) formula

11. Have received a gene or cell therapy at any time

12. Are unwilling to use two forms of contraception (one of which being a barrier method)
   for 90 days post-dosing, if relevant

13. Active malignancy within the past 12 months, except for: appropriately treated
   carcinoma in situ of the cervix, non-melanoma skin carcinoma, or prostate cancer with
   a stable prostate-specific antigen (PSA) >12 months

Ages Eligible for Study

55 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting