Authorised Therapeutic confirmatory (Phase III) Geographic Atrophy

PHase 3, Multicenter, RandOmized, Double-masked, PlacEbo-CoNtrolled Study of TInlarebant to EXplore Safety and Efficacy in the Treatment of Geographic Atrophy (the PHOENIX Study)

EU CTIS ID: 2023-503931-17-00

What this study is testing

To measure the rate of change (growth rate slope) in geographic atrophy (GA) lesion size as determined by fundus autofluorescence (FAF) photography from baseline to Month 24

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. Subjects must be willing and able to provide signed informed consent prior to participation in any study-related procedures.
2. Males or females, 60 to 85 years of age.
3. Subjects must have a confirmed diagnosis of GA with atrophic lesions (diagnosed as GA) in 1 or both eyes, measuring 0.5 to 10 mm2 in aggregate area as assessed by FAF photography and determined by a central reading center. - For lesions with foveal involvement, BCVA in the study eye should be 20/80 or better (≥ 54 ETDRS letters) - For lesions without any foveal involvement, BCVA in the study eye should be 20/100 or better (≥ 49 ETDRS letters) - No minimum BCVA is required in the fellow eye
4. Ability to adequately examine the study eye fundus at enrollment (the subject must have sufficiently clear ocular media, adequate pupillary dilation, fixation to permit quality fundus imaging, and the ability to cooperate sufficiently for adequate ophthalmic visual function testing).
5. Female subjects must be nonpregnant and nonlactating. Male subjects whose partners are fertile, and women of childbearing potential (WOCBP) must use only highly effective contraception methods for the entire study duration and not donate sperm or eggs throughout the entire study from the date of informed consent until 89 days (WOCBP) or 149 days (men) after the last dose of the study treatment in case of early treatment termination.

You likely can't join if

1. Any GA lesions larger than 10 mm2 in the study eye.
6. Presence or history of choroidal neovascularization (CNV) in the study eye as determined by optical coherence tomography angiography (OCT-A) and confirmed by a central reading center. If OCT-A results are inconclusive to confirm the presence/absence of CNV, as determined by central imaging center, fluorescein angiography may be performed at the discretion of the Study Investigator. Upon Sponsor’s approval in advanced, fluorescein angiography could be performed and assessed by the Study Investigator and designee, to replace OCT-A if site does not have feasible device.
7. Inflammatory disease of the retina, uvea, or choroid in either eye within 1 year of study enrollment.
8. Any form of uncontrolled glaucoma in the study eye based on the criteria below assessed at Screening: - Intraocular pressure > 25 mm Hg - Glaucomatous visual field, or disc cupping considered clinically significant (CS) for advanced glaucoma (cup to-disc ratio > 0.6).
9. Severe dry eye disease.
14. Any prior or current use of retinotoxic drugs.

See the full eligibility criteria

Who can join

1. Subjects must be willing and able to provide signed informed consent prior to participation in any study-related procedures.
2. Males or females, 60 to 85 years of age.
3. Subjects must have a confirmed diagnosis of GA with atrophic lesions (diagnosed as GA) in 1 or both eyes, measuring 0.5 to 10 mm2 in aggregate area as assessed by FAF photography and determined by a central reading center. - For lesions with foveal involvement, BCVA in the study eye should be 20/80 or better (≥ 54 ETDRS letters) - For lesions without any foveal involvement, BCVA in the study eye should be 20/100 or better (≥ 49 ETDRS letters) - No minimum BCVA is required in the fellow eye
4. Ability to adequately examine the study eye fundus at enrollment (the subject must have sufficiently clear ocular media, adequate pupillary dilation, fixation to permit quality fundus imaging, and the ability to cooperate sufficiently for adequate ophthalmic visual function testing).
5. Female subjects must be nonpregnant and nonlactating. Male subjects whose partners are fertile, and women of childbearing potential (WOCBP) must use only highly effective contraception methods for the entire study duration and not donate sperm or eggs throughout the entire study from the date of informed consent until 89 days (WOCBP) or 149 days (men) after the last dose of the study treatment in case of early treatment termination.

What rules you out

1. Any GA lesions larger than 10 mm2 in the study eye.
6. Presence or history of choroidal neovascularization (CNV) in the study eye as determined by optical coherence tomography angiography (OCT-A) and confirmed by a central reading center. If OCT-A results are inconclusive to confirm the presence/absence of CNV, as determined by central imaging center, fluorescein angiography may be performed at the discretion of the Study Investigator. Upon Sponsor’s approval in advanced, fluorescein angiography could be performed and assessed by the Study Investigator and designee, to replace OCT-A if site does not have feasible device.
7. Inflammatory disease of the retina, uvea, or choroid in either eye within 1 year of study enrollment.
8. Any form of uncontrolled glaucoma in the study eye based on the criteria below assessed at Screening: - Intraocular pressure > 25 mm Hg - Glaucomatous visual field, or disc cupping considered clinically significant (CS) for advanced glaucoma (cup to-disc ratio > 0.6).
9. Severe dry eye disease.
14. Any prior or current use of retinotoxic drugs.
15. Investigational drug use of any kind in the previous 3 months.
16. Any prior ocular gene therapy.
17. Any prior intraocular, periocular, or intravitreal injection of any drug in the either eye in the previous 3 months.
18. Prior macular laser photocoagulation treatment or any history of photodynamic therapy in the study eye. Prior extramacular laser photocoagulation treatment is allowed, but not within 1 year prior to enrollment in the study.
19. Use of any known drugs or supplements that are inhibitors/inducers of cytochrome P450 enzymes (e.g., Clarithromycin, Fluvoxamine, Ketoconazole, Rifampin, Carbamazepine, St. John’s wort) starting within 30 days of first study treatment administration, or regular consumption of foods that are inhibitors/inducers of cytochrome P450 enzymes (e.g., grapefruit, pomegranate, star fruit, bitter orange [Seville orange]) starting within 48 hours of first study treatment administration that, in the investigator’s judgment, may impact subject safety or the validity of the study results.
10. Myopia > -8 D in the study eye.
20. Use of Pentosan Polysulfate Sodium (e.g. ELMIRON®) 30 days prior to the first study treatment dose and during the study.
21. Use of breast cancer resistance protein inhibitors that cannot be stopped within 30 days prior to the first study treatment dose and during the study (e.g., Cyclosporine A, Darolutamide, Fostamatinib).
22. Presence of life-threatening disease(s), including malignancies requiring current treatment.
23. Abnormal cardiac rhythm not controlled with medication or history of stroke, coronary events, and/or heart failure within 1 year prior to enrollment.
24. Uncontrolled hypertension as defined by blood pressure ≥ 160 systolic or ≥ 100 diastolic (note: investigator to take the better of at least 2 measurements).
25. Alanine aminotransferase/aspartate aminotransferase > 2.5 × the upper limit of normal.
26. Previous diagnosis of Moderate, Severe, or End Stage kidney disease (Stages 3B – 5), estimated Glomerular filtration rate (eGFR) of 44 mL/min/1.73m2 or less), or current use of medications to manage cardiovascular risk associated with chronic kidney disease.
27. Body mass index ≥ 40.
28. Hemoglobin A1c ≥ 8%.
29. Unwillingness or inability to provide signed informed consent prior to participation in any study-related procedures.
11. Hypermetropia > +8 D in the study eye.
30. Pregnant or nursing female subjects; women of childbearing potential who are unwilling or unable to use an acceptable method of contraception (or abstinence). Women of childbearing age must have a negative pregnancy test prior to randomisation.
31. Male subjects who are unwilling or unable to use an acceptable method of contraception (or abstinence) and who do not agree that female spouses/partners will use adequate contraception or be of nonchildbearing potential (i.e., surgically sterile).
12. Current use and unwillingness to discontinue oral prescription-strength retinoid-based products. Subjects who discontinue oral use of the prescription-strength retinoid-based products for a period of at least 30 days prior to Screening may be considered for enrollment. Ocular topical medications containing retinoids and vitamin A-based drugs or medications should be stopped at least 30 days prior to Screening.
13. Use of systemic medications and nonprescription supplements containing vitamin A or vitamin A derivatives during the study. Use of these medications or supplements must be stopped at least 30 days prior to Screening, or within the washout period of the medication, whichever is longer. Multivitamin supplements not containing vitamin A or vitamin A derivatives are allowed. The use of topical medications (except topical ophthalmological medications) containing vitamin A or vitamin A derivatives is allowed. Topical ophthalmic medications that do not contain vitamin A or vitamin A derivatives are allowed.
2. The presence of diabetic macular edema or macular disease in either eye.
3. Diabetic retinopathy more advanced than mild nonproliferative diabetic retinopathy, or any other retinal vascular disease in either eye.
4. Plans to undergo inpatient surgical procedures during the study.
5. Incisional ocular surgery in the study eye 3 months prior to screening and/or plans to undergo intraocular surgery (including cataract surgery) in the study eye during the study. a) Cataract surgery is allowed when done more than 8 weeks prior to Screening. b) YAG capsulotomy and laser iridotomy are allowed when done more than 4 weeks prior to Screening. c) Any postoperative treatment regimen following the above interventions needs to be terminated more than 4 weeks prior to Screening.

The study team makes the final eligibility decision.

Where it's taking place

United Kingdom
Taiwan
Australia
United States
China
Switzerland

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; Taiwan; Australia; United States; China; Switzerland. 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.