Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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
Funding Agency/Sponsor
Industry
Disease
Retina
Enrollment 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