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

• Status: Recruiting
• Trial end date: 2024-02-28
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gyroscope Therapeutics; Gyroscope Therapeutics Limited

Criteria

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