Authorised Therapeutic confirmatory (Phase III) Dry Age-Related Macular Degeneration (AMD) with geographic atrophy (GA)

A Study Investigating the Efficacy and Safety of Intravitreal Injections of ANX007 in Participants with Dry Age-Related Macular Degeneration with Geographic Atrophy

EU CTIS ID: 2024-515022-88-00

What this study is testing

To evaluate efficacy of intravitreal (IVT) injections of ANX007 on visual function and visual acuity

Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1. Fellow eyes treated with an approved anti-complement drug or other locally-administered treatment for GA that was initiated at least 4 weeks prior to randomization may continue treatment with no washout. Fellow eyes treated with an approved therapy for GA for fewer than 4 weeks should not be randomized in the study. GA -treatment-naive fellow eyes should, in the opinion of the Investigator, be unlikely to need treatment for GA in the fellow eye for at least the first year of the study.
2. Participant must be at least 50 years of age at the time of signing the informed consent.
3. Able and willing to participate in a 24-month study with monthly visits.
4. Diagnosis of dry AMD with GA as determined by the Investigator and confirmed by the independent Central Reading Center.
5. The GA lesion must have the following characteristics as determined by the independent Central Reading Center based on assessment of FAF imaging at screening. If both eyes are confirmed to be eligible by the independent Central Reading Center, the determination of the study eye selection is in the opinion of the Investigator. a. Well-demarcated GA with a total area (baseline lesion size) ≥2.5 mm2 and ≤ 17.5 mm2. b. If GA is multifocal, at least one focal lesion must measure ≥1.25 mm2 with the overall aggregate area of GA as specified above in 5a. c. Presence of hyper autofluorescence, any pattern, in the junctional zone of the GA. Absence of hyper autofluorescence (ie., pattern = none) is exclusionary. d. The entire GA lesion must be completely visualized on the macula centered image and must be able to be imaged in its entirety and not contiguous with any peripapillary atrophy.
6. Normal luminance BCVA of 45 to 83 letters using ETDRS methodology(20/25 to 20/100 Snellen equivalent, inclusive). a. [CCI]

You likely can't join if

1. Geographic atrophy due to other causes than AMD such as Stargardt disease, cone-rod dystrophy, pathologic myopia, or toxic maculopathies (eg, plaquenil maculopathy) in either eye.
10. History of idiopathic, autoimmune-associated, or other uveitis in either eye."
11. Any current or prior ocular condition, other than dry AMD with GA, that in the opinion of the Investigator could interfere with the conduct of the study (including, but not limited to, insufficient pupil dilation, retinal or optic nerve disease, media opacity, or aphakia in the study eye).
12. History of any prior IVT treatment for any indication in the study eye.
13. Any prior treatment for AMD in the study eye ( including investigational treatments, eg, pharmacological, surgical, radiation, thermotherapeutic, light therapy, or laser intervention), or systemic anti-GA or anti-complement treatment (including investigational treatments). NOTE: Oral supplements (multivitamins/minerals, eg, AREDS vitamins) are permitted during the study.
14. Previous participation in any studies of investigational medications not already prohibited by Exclusions 12 and 13, within 3 months or 5 half-lives of the active ingredient (whichever is longer) prior to the start of study treatment.

See the full eligibility criteria

Who can join

1. Fellow eyes treated with an approved anti-complement drug or other locally-administered treatment for GA that was initiated at least 4 weeks prior to randomization may continue treatment with no washout. Fellow eyes treated with an approved therapy for GA for fewer than 4 weeks should not be randomized in the study. GA -treatment-naive fellow eyes should, in the opinion of the Investigator, be unlikely to need treatment for GA in the fellow eye for at least the first year of the study.
2. Participant must be at least 50 years of age at the time of signing the informed consent.
3. Able and willing to participate in a 24-month study with monthly visits.
4. Diagnosis of dry AMD with GA as determined by the Investigator and confirmed by the independent Central Reading Center.
5. The GA lesion must have the following characteristics as determined by the independent Central Reading Center based on assessment of FAF imaging at screening. If both eyes are confirmed to be eligible by the independent Central Reading Center, the determination of the study eye selection is in the opinion of the Investigator. a. Well-demarcated GA with a total area (baseline lesion size) ≥2.5 mm2 and ≤ 17.5 mm2. b. If GA is multifocal, at least one focal lesion must measure ≥1.25 mm2 with the overall aggregate area of GA as specified above in 5a. c. Presence of hyper autofluorescence, any pattern, in the junctional zone of the GA. Absence of hyper autofluorescence (ie., pattern = none) is exclusionary. d. The entire GA lesion must be completely visualized on the macula centered image and must be able to be imaged in its entirety and not contiguous with any peripapillary atrophy.
6. Normal luminance BCVA of 45 to 83 letters using ETDRS methodology(20/25 to 20/100 Snellen equivalent, inclusive). a. [CCI]
7. A female participant is eligible if she is not pregnant or breastfeeding, and one of the following conditions applies: o Is a woman of non-childbearing potential (WONCBP) (defined as having undergone surgical sterilization or being postmenopausal [ie, greater than 50 years old with amenorrhea for at least 12 months without an alternative medical cause]). OR o Is a WOCBP using an acceptable contraceptive method during the study intervention period and for at least 30 days after the last dose of study intervention. • WOCBP must have a negative pregnancy test (PT) within 24 hours before the first dose of study intervention. • The Investigator has reviewed medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
8. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol.

What rules you out

1. Geographic atrophy due to other causes than AMD such as Stargardt disease, cone-rod dystrophy, pathologic myopia, or toxic maculopathies (eg, plaquenil maculopathy) in either eye.
10. History of idiopathic, autoimmune-associated, or other uveitis in either eye."
11. Any current or prior ocular condition, other than dry AMD with GA, that in the opinion of the Investigator could interfere with the conduct of the study (including, but not limited to, insufficient pupil dilation, retinal or optic nerve disease, media opacity, or aphakia in the study eye).
12. History of any prior IVT treatment for any indication in the study eye.
13. Any prior treatment for AMD in the study eye ( including investigational treatments, eg, pharmacological, surgical, radiation, thermotherapeutic, light therapy, or laser intervention), or systemic anti-GA or anti-complement treatment (including investigational treatments). NOTE: Oral supplements (multivitamins/minerals, eg, AREDS vitamins) are permitted during the study.
14. Previous participation in any studies of investigational medications not already prohibited by Exclusions 12 and 13, within 3 months or 5 half-lives of the active ingredient (whichever is longer) prior to the start of study treatment.
15. Known hypersensitivity to ANX007 or any of the excipients in the ANX007 solution (as described in the ANX007 Investigator’s Brochure or other ANX molecules (eg ANX005).
16. Known hypersensitivity to fluorescein
17. Active alcohol or substance abuse/dependence or any other reason that makes it unlikely that the participant will comply with study procedures.
18. History of current systemic medical or psychiatric conditions or any other reason, including laboratory findings, that may, in the opinion of the Investigator, contraindicate the use of an investigational medication, affect interpretation of study results, preclude adherence to the study visit schedule, or safe participation in the study.
2. Any evidence of CNV in the study eye: a. Any history of CNV of any cause based on medical history. b. Evidence of prior or active CNV or related findings (eg, retinal pigment epithelial rips or tears) based on FAF, SD-OCT imaging, intravenous fluorescein angiography (IVFA), and color fundus photo as assessed by the Central Reading Center.
3. Spherical equivalent of -8.00 diopters (D) myopia or higher in the study eye.
4. Uncontrolled glaucoma in the study eye (Intraocular pressure (IOP) >25 mmHg despite treatment with anti-glaucoma medication) or history of neovascular glaucoma.
5. History of incisional glaucoma surgery (eg, glaucoma filtration surgery, minimally invasive glaucoma surgery implantation of a drainage device); vitrectomy surgery; or other procedure in the study eye that could affect drug distribution and/or clearance.
6. History of cataract surgery less than 3 months prior to dosing in the study eye (cataract surgery should have been uncomplicated to be considered eligible).
7. Any ophthalmic condition that may require surgery during the study period in the study eye
8. Ocular trauma in the study eye within the preceding 6 months.
9. Any active ocular/intraocular infection or inflammation in either eye (e.g., blepharitis, infectious conjunctivitis, keratitis, scleritis, endophthalmitis, uveitis).

The study team makes the final eligibility decision.

Where it's taking place

United Kingdom
New Zealand
United States
Australia
Canada

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United Kingdom; New Zealand; United States; Australia; Canada. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.