A Study to Determine Safety and Long-Term Effectiveness of Faricimab in Participants with Age-Related Macular Degeneration

Overview

Sponsor-declared trial summary

Key facts

Sponsor

F. Hoffmann-La Roche AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

4 Jun 2025 → ongoing

Decision date (initial)

2025-06-03

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

F. Hoffmann La Roche

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the efficacy of intravitreal (IVT) injections of faricimab in the study eye following the regimen in each of the treatment arms as change from baseline in best corrected visual acuity (BCVA) averaged over Weeks 44, 48, and 52

Secondary objectives 4

1. To evaluate the efficacy of IVT injections of faricimab on additional BCVA outcomes in the study eye
2. To evaluate the efficacy of IVT injections of faricimab on anatomic outcomes using optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA) in the study eye
3. To evaluate the durability of IVT injections of faricimab in the study eye
4. To evaluate the ocular and non-ocular safety and tolerability of IVT injections of faricimab

Conditions and MedDRA coding

Neovascular Age-Related Macular Degeneration

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Age ≥50 years at the time of signing Informed Consent Form
2. Overtly healthy as determined by medical evaluation that includes medical history and physical examination.
3. Agreement to adhere to the contraception requirements described
4. Ocular Inclusion Criteria for Study Eye: Active treatment-naïve macular neovascularization (MNV) secondary to age-related macular degeneration (AMD), confirmed by the Investigator based on the presence of intraretinal fluid (IRF) or subretinal fluid (SRF) affecting the central subfield on OCT.
5. Ocular Inclusion Criteria for Study Eye: BCVA of 83 to 24 letters, inclusive (20/25 to 20/320 approximate Snellen equivalent, using the early treatment diabetic retinopathy study (ETDRS) protocol and addressed at the initial testing distance of 4 meters on Day 1).
6. Ocular Inclusion Criteria for Study Eye:Sufficiently clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis.

Exclusion criteria 6

1. Macular neovascularization due to causes other than AMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis.
2. Retinal pigment epithelial tear involving the macula on Day 1
3. Current vitreous hemorrhage on Day 1
4. Prior periocular pharmacological or IVT treatment (including faricimab, anti-vascular endothelial growth factor (VEGF), or complement inhibitor medication) for other retinal diseases
5. Ocular Exclusion Criteria for Fellow (Non-Study) Eye Participants who have a nonfunctioning fellow (non-study) eye, defined as either BCVA of hand motion or worse, or no physical presence of non-study eye (i.e., monocular), at both the screening and study Day 1 visits will be excluded from study entry
6. Ocular Exclusion for Both Eyes Potential participants are excluded from the study if any of the following criteria apply: – History of idiopathic or autoimmune associated uveitis in either eye – Active ocular inflammation or suspected or active ocular or periocular infection in either eye on study Day 1

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline in BCVA score as measured using the ETDRS VA chart at a starting distance of 4 meters

Secondary endpoints 8

1. Change from baseline in BCVA averaged over Weeks 92, 96, and 100
2. Change from baseline in BCVA over time
3. Change from baseline in central subfield thickness (CST) averaged over Weeks 44, 48, and 52
4. Change from baseline in CST averaged over Weeks 92, 96, and 100
5. Change from baseline in CST over time
6. Proportion of participants on a Q4W, Q8W, Q12W, Q16W, Q20W, and Q24W treatment interval at Weeks 52 and 100
7. Incidence and severity of ocular adverse events
8. Incidence and severity of non-ocular adverse events

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

F. Hoffmann-La Roche AG

Sponsor organisation

F. Hoffmann-La Roche AG

Address

Grenzacherstrasse 124

City

Basel

Postcode

4058

Country

Switzerland

Scientific contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Public contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Third parties 9

Locations

4 EU/EEA countries · 24 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 49 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications