Condition

• Geographic Atrophy Secondary to Age-related Macular Degeneration

Eligibility

Eligible Ages

Over 55 Years

Eligible Sex

All

Accepts Healthy Volunteers

No

Criteria

Inclusion:

1. Participants must be aged ≥55 years, at the time of signing the informed consent at
the screening visit.

2. Participants with bilateral GA secondary to AMD as confirmed by the Central Reading
Center using FAF and/or OCT images with at least 1 eye having a total GA lesion area
must be between 1.25 mm2 and 17.5 mm2 inclusive, determined by FAF images taken at
the screening visit.

3. Best-corrected visual acuity (BCVA) in both eyes should be sufficient to ensure
navigational vision (defined as 20/400 or better for purposes of this study).

4. BCVA between 20 and 75 letters and LLVA>0 letters using an ETDRS chart.

5. Mean retinal sensitivity as measured by microperimetry using the study grid must be
equal to or greater than 5 dB.

6. Able and willing to provide signed informed consent which includes compliance with
the requirements and restrictions listed in the informed consent form (ICF) and in
this protocol, and in the opinion of the investigator, is able to perform all study
assessments.

Exclusion criteria:

1. Macular atrophy secondary to any condition other than AMD in the study eye.

2. Any pathology of the macula other than GA secondary to AMD and other changes
consistent with early, intermediate or atrophic AMD in the study eye.

3. Evidence of prior or current Choroidal Neovascularization (CNV), also known as
wet-AMD, in either eye.

4. Atrophic retinal disease of causality other than AMD including monogenetic macular
dystrophies (incorporating pattern dystrophy), myopia-related maculopathy and
Stargardt disease in the study eye.

5. A history of vitrectomy in the study eye.

6. Any prior treatment for AMD or any prior intravitreal treatment for any indication
in the study eye, except oral supplements of vitamins and minerals such as the
age-related eye disease study (AREDS) formula.

7. Any intraocular surgery (except cataract surgery within 6 months of enrollment) or
thermal laser within 3 months of screening, or any ophthalmic condition that may
require surgery during the study.

8. Any macular laser, macular surgery or retinal surgery at any time point in the study
eye.

9. Any ocular or periocular infection in the 12 weeks prior to screening.

10. History of uveitis or endophthalmitis in either eye.

11. Any sign of diabetic retinopathy in either eye, or HbA1c >8, in the 12 months prior
to enrollment.

12. High myopia or hyperopia (≥6 diopter) in the study eye.

13. Uncontrolled IOP measurement of ≥25 mmHg for >1 month despite being on 2 or more
ocular hypotensive agents, or IOP >21 mm Hg in the presence of C/D asymmetry of >0.3
per the reading center; or glaucomatous damage to the optic nerve or visual field.

14. Retinal disease other than AMD or other ocular disorders which may cause safety
concerns per the judgment of the investigator; however, benign conditions of the
vitreous or peripheral retina are not exclusionary (i.e., paving stone
degeneration).

15. Any ophthalmologic condition that reduces the clarity of the media and that, in the
opinion of the investigator interferes with ophthalmologic examination (e.g.,
cataract or corneal abnormalities) either at the time of enrollment or during the
2-year post dosing follow-up period; or prevents adequate imaging of the retina
judged by the site or CRC.

16. Aphakia or absence of the posterior capsule. Previous violation of the posterior
capsule is also excluded unless it occurred as a result of yttrium aluminum garnet
(YAG) laser posterior capsulotomy in association with prior posterior chamber
intraocular lens implantation and at least 60 days prior to baseline.

17. Medical or psychiatric conditions that, in the opinion of the investigator, make
consistent follow-up over the treatment period unlikely, or in general a poor
medical risk because of other systemic diseases or active uncontrolled infections,
including but not limited to immunodeficiency state, autoimmune diseases, malignancy
other than prostate or basal cell carcinoma, connective tissue disorders and
collagen vascular disorders.

18. Participation in an interventional clinical study, or use of any experimental
treatment for AMD or any investigational product within 6 months or 5 half-lives of
the active ingredient (whichever is longer) prior to screening.

19. History of abnormal laboratory tests (e.g. hematology, serum chemistry, renal or
liver function tests, or infectious disease screen) that in the opinion of the
investigator is clinically significant at the time of enrollment and not suitable
for study participation.

20. Hypersensitivity to medications used in (standard of care) study procedures.

21. Situations where, in the opinion of the investigator, the risk of harm to a
participant outweighs any potential benefits from study participation (these could
include participants with conditions such as brittle diabetes or advanced
osteoporosis as examples).

22. History or current use of medications associated with macular changes, retinal
dysfunction or optic nerve damage. These include but are not limited to the
following prohibited concomitant medications:

23. Any previous gene or cell therapy (ophthalmic or systemic),

24. Chloroquine (where taken for >30 days cumulative across participant's lifetime),
hydroxychloroquine, platinum containing medications, ethambutol, tamoxifen,
pentosan, chronic use of phosphodiesterase inhibitors, and GLP-1 antagonists in the
setting of a crowded optic disc.

Recruiting Locations

Study Contact