A Study to Evaluate the Efficacy and Safety of Faricimab in Patients with Choroidal Neovascularization Secondary to Pathologic Myopia

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

9 Apr 2024 → 22 May 2026

Decision date (initial)

2024-03-26

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

F. Hoffmann-La Roche AG

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

1. To evaluate the efficacy of intravitreal (IVT) injections of faricimab compared with ranibizumab

Secondary objectives 6

1. 1. To evaluate the efficacy of faricimab compared with ranibizumab on best-corrected visual acuity (BCVA) outcomes
2. 2. To evaluate the frequency of faricimab administration compared with ranibizumab
3. 3. To evaluate the efficacy of faricimab compared with ranibizumab on anatomic outcomes using optical coherence tomography (OCT)
4. 4. To evaluate the efficacy of faricimab compared with ranibizumab on anatomic outcomes using color fundus photography/fundus fluorescein angiography (CFP/FFA)
5. 5. To evaluate the safety of faricimab compared with ranibizumab
6. 6. To evaluate the immune response to faricimab

Conditions and MedDRA coding

Choroidal neovascularization secondary to pathologic myopia

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 1. Overtly healthy as determined by medical evaluation that includes medical history, physical examination, and laboratory tests
2. 2. Treatment-naïve choroidal neovascularization (CNV) secondary to myopia
3. 3. Diagnosis of active myopic CNV in the study eye confirmed by ocular examination and CRC review
4. 4. BCVA of 78 to 24 letters, inclusive (20/32 to 20/320 approximate Snellen equivalent), using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and assessed at the initial testing distance of 4 meters (see the BCVA manual for additional details) on Day 1
5. 5. Presence of at least 1 of the following lesion types (determined by CRC): Subfoveal (presence of abnormal neovasculature in the avascular central fovea) Juxtafoveal (presence of abnormal neovasculature not under the center of the fovea but ≤ 200 um from the center) with involvement of the central macular area Extrafoveal (presence of abnormal neovasculature > 200 um from the center of the fovea) with involvement of the central macular area Margin of the optic disc (presence of abnormal neovasculature at peripapillary area) with involvement of the central macular area
6. 6. Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis

Exclusion criteria 6

1. 1. CNV due to causes other than pathologic myopia, such as neovascular age-related macular degeneration, ocular histoplasmosis, trauma, angioid streaks, choroidal rupture, or uveitis, etc
2. 2. Any history of macular pathology unrelated to pathologic myopia affecting vision or contributing to the presence of intraretinal or subretinal fluid
3. 3. Presence at screening of central serous chorioretinopathy or myopic tractional maculopathy. Retinal pigment epithelial tear involving the macula on Day 1
4. 4. Non-functioning non-study eye, defined as either: BCVA Snellen equivalent of 20/200 or worse No physical presence of non-study eye (i.e., monocular)
5. 5. Prior IVT administration of faricimab in either eye
6. 6. History of idiopathic or autoimmune-associated uveitis in either eye. Active ocular inflammation (anterior, intermediate or posterior uveitis, grade trace or above) or suspected or active ocular or periocular infection in either eye on Day 1

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1. Change from baseline in BCVA averaged over Weeks 4, 8, and 12

Secondary endpoints 22

1. 1. Change from baseline in BCVA over time
2. 2. Proportion of patients gaining ≥15 letters averaged over Weeks 4, 8, and 12
3. 3. Proportion of patients gaining ≥15 letters in BCVA from baseline over time
4. 4. Proportion of patients avoiding loss of ≥15 letters in BCVA from baseline over time
5. 5. Proportion of patients gaining ≥15 letters or achieving BCVA of ≥84 letters over time
6. 6. Proportion of patients with BCVA Snellen equivalent of 20/40 or better over time
7. 7. Proportion of patients with BCVA Snellen equivalent of 20/200 or worse over time
8. 8. Proportion of patients only receiving one injection from baseline to Week 12
9. 9. Proportion of patients only receiving one injection from baseline to Week 24
10. 10. Proportion of patients only receiving one injection from baseline to Week 48
11. 11. Number of IVT injections received by Week 12
12. 12. Number of IVT injections received by Week 24
13. 13. Number of IVT injections received by Week 48
14. 14. Change from baseline in central subfield thickness (CST) of the study eye averaged over Weeks 4, 8, and 12
15. 15. Change from baseline in CST of the study eye over time
16. 16. Change from baseline in total area of CNV lesion at Week 12 and Week 48
17. 17. Change from baseline in total area of CNV leakage at Week 12 and Week 48
18. 18. Proportion of patients with absence of macular leakage at Week 12 and Week 48
19. 19. Incidence and severity of ocular adverse events
20. 20. Incidence and severity of non-ocular adverse events
21. 21. Prevalence of ADAs at baseline and incidence of ADA during the study
22. 22. Relationship between ADA status and efficacy or safety endpoints

Investigational products

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

Test 1

Comparator 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 7

Locations

5 EU/EEA countries · 40 investigational sites

By country

Investigational sites

Country notifications

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

Results and documents

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

Documents 23 files

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

Application history

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