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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06176352




Registration number
NCT06176352
Ethics application status
Date submitted
11/12/2023
Date registered
19/12/2023

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Pathologic Myopia
Scientific title
A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Pathologic Myopia
Secondary ID [1] 0 0
2023-506707-25-00
Secondary ID [2] 0 0
CR44829
Universal Trial Number (UTN)
Trial acronym
POYANG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Choroidal Neovascularization Secondary to Pathologic Myopia 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Faricimab
Treatment: Drugs - Ranibizumab
Treatment: Surgery - Sham Procedure

Experimental: Arm A: Faricimab - All participants randomly assigned to Arm A will receive faricimab 6 mg at Day 1. Once every 4 weeks (Q4W) after Day 1, participants will receive treatment with faricimab on a pro re nata (PRN) basis dependent on prespecified retreatment criteria.

Active comparator: Arm B: Ranibizumab - All participants randomly assigned to Arm B will receive ranibizumab 0.5 mg at Day 1. Once every 4 weeks (Q4W) after Day 1, participants will receive treatment with ranibizumab on a pro re nata (PRN) basis dependent on prespecified retreatment criteria.


Treatment: Drugs: Faricimab
Faricimab 6 mg intravitreal (IVT) injection on Day 1 with Q4W PRN treatment thereafter to Week 44. At Week 48, participants will attend a follow-up visit.

Treatment: Drugs: Ranibizumab
Ranibizumab 0.5 mg intravitreal (IVT) injection on Day 1 with Q4W PRN treatment thereafter to Week 44. At Week 48, participants will attend a follow-up visit.

Treatment: Surgery: Sham Procedure
The sham is a procedure that mimics an intravitreal (IVT) injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. Participants will undergo the sham procedure at study visits where no study drug is to be administered, in order to maintain masking.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline in Best-Corrected Visual Acuity (BCVA) Averaged Over Weeks 4, 8, and 12
Timepoint [1] 0 0
Baseline and Average of Weeks 4, 8, and 12
Secondary outcome [1] 0 0
Change from Baseline in BCVA Over Time
Timepoint [1] 0 0
From Baseline through Week 48
Secondary outcome [2] 0 0
Percentage of Participants Gaining =15 Letters in BCVA from Baseline Averaged Over Weeks 4, 8, and 12
Timepoint [2] 0 0
Baseline and Average of Weeks 4, 8, and 12
Secondary outcome [3] 0 0
Percentage of Participants Gaining =15 Letters in BCVA from Baseline Over Time
Timepoint [3] 0 0
From Baseline through Week 48
Secondary outcome [4] 0 0
Percentage of Participants Avoiding a Loss of =15 Letters in BCVA from Baseline Over Time
Timepoint [4] 0 0
From Baseline through Week 48
Secondary outcome [5] 0 0
Percentage of Participants Gaining =15 Letters in BCVA from Baseline or Achieving a BCVA of =84 Letters Over Time
Timepoint [5] 0 0
From Baseline through Week 48
Secondary outcome [6] 0 0
Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better Over Time
Timepoint [6] 0 0
From Baseline through Week 48
Secondary outcome [7] 0 0
Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse Over Time
Timepoint [7] 0 0
From Baseline through Week 48
Secondary outcome [8] 0 0
Percentage of Participants Only Receiving One Injection From Baseline to Weeks 12, 24, and 48
Timepoint [8] 0 0
From Baseline to Weeks 12, 24, and 48
Secondary outcome [9] 0 0
Number of Intravitreal Injections Received From Baseline to Weeks 12, 24, and 48
Timepoint [9] 0 0
From Baseline to Weeks 12, 24, and 48
Secondary outcome [10] 0 0
Change from Baseline in Central Subfield Thickness (CST) of the Study Eye Averaged Over Weeks 4, 8, and 12
Timepoint [10] 0 0
Baseline and Average of Weeks 4, 8, and 12
Secondary outcome [11] 0 0
Change from Baseline in CST of the Study Eye Over Time
Timepoint [11] 0 0
From Baseline through Week 48
Secondary outcome [12] 0 0
Change from Baseline in Total Area of the Choroidal Neovascularization Lesion at Weeks 12 and 48
Timepoint [12] 0 0
Baseline, Weeks 12 and 48
Secondary outcome [13] 0 0
Change from Baseline in Total Area of the Choroidal Neovascularization Leakage at Weeks 12 and 48
Timepoint [13] 0 0
Baseline, Weeks 12 and 48
Secondary outcome [14] 0 0
Percentage of Participants with Absence of Macular Leakage at Weeks 12 and 48
Timepoint [14] 0 0
Weeks 12 and 48
Secondary outcome [15] 0 0
Incidence and Severity of Ocular Adverse Events
Timepoint [15] 0 0
From first dose until 35 days after the last dose of study treatment (up to 48 weeks)
Secondary outcome [16] 0 0
Incidence and Severity of Non-Ocular Adverse Events
Timepoint [16] 0 0
From first dose until 35 days after the last dose of study treatment (up to 48 weeks)
Secondary outcome [17] 0 0
Prevalence of Anti-Drug Antibodies (ADAs) at Baseline and Incidence of ADAs During the Study
Timepoint [17] 0 0
At Baseline and from first dose until end of study (up to 48 weeks)

Eligibility
Key inclusion criteria
1. Treatment-naïve choroidal neovascularization (CNV) secondary to myopia
2. Diagnosis of active myopic CNV in the study eye:

1. Presence of high myopia, worse than -6 diopters of spherical equivalence
2. Antero-posterior elongation measurement greater than or equal to 26.0 mm
3. Presence of posterior changes compatible with pathologic myopia (e.g., tessellated fundus, lacquer cracks, etc.)
4. Presence of active leakage from CNV on FFA (determined by Central Reading Centre [CRC])
5. Presence of intraretinal or subretinal fluid or increase of CST on OCT (determined by CRC)
3. BCVA of 78 to 24 letters, inclusive (20/32 to 20/320 approximate Snellen equivalent), using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol on Day 1
4. Overtly healthy as determined by medical evaluation that includes medical history, physical examination, and laboratory tests
5. Ability to comply with the study protocol, in the Investigator's judgment
6. Other protocol-defined inclusion criteria apply
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any major illness or major surgical procedure within 1 month before screening
2. Pregnancy or breastfeeding, or intention to become pregnant during the study or within 3 months after the final study treatment administration
3. Uncontrolled blood pressure (systolic >180 millimetres of mercury [mmHg], diastolic >100 mmHg)
4. Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Day 1
5. History of systemic or ocular disease that would contraindicate treatment with the investigational drug or comparator
6. Uncontrolled glaucoma in study eye
7. Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities, including, but not restricted to, intravitreal, periocular or laser interventions in study eye
8. Prior or concomitant periocular or intravitreal pharmacological treatment, including anti-VEGF medication, for other retinal diseases (e.g. geography atrophy, nAMD, DME etc.) in study eye
9. Other protocol-defined exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2026
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
South West Retina - Liverpool
Recruitment hospital [2] 0 0
Strathfield Retina Clinic - Strathfield
Recruitment hospital [3] 0 0
Sydney Eye Hospital - Sydney
Recruitment hospital [4] 0 0
Sydney Retina Clinic and Day Surgery - Sydney
Recruitment hospital [5] 0 0
Centre For Eye Research Australia - East Melbourne
Recruitment hospital [6] 0 0
Retina Specialists Victoria - Rowville
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2135 - Strathfield
Recruitment postcode(s) [3] 0 0
2000 - Sydney
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
3178 - Rowville
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing City
Country [2] 0 0
China
State/province [2] 0 0
Beijing
Country [3] 0 0
China
State/province [3] 0 0
Changchun
Country [4] 0 0
China
State/province [4] 0 0
Guangzhou City
Country [5] 0 0
China
State/province [5] 0 0
Harbin
Country [6] 0 0
China
State/province [6] 0 0
Qingdao
Country [7] 0 0
China
State/province [7] 0 0
Shanghai City
Country [8] 0 0
China
State/province [8] 0 0
Shanghai
Country [9] 0 0
China
State/province [9] 0 0
Shenyang
Country [10] 0 0
China
State/province [10] 0 0
Taiyuan City
Country [11] 0 0
China
State/province [11] 0 0
Tianjin City
Country [12] 0 0
China
State/province [12] 0 0
Wenzhou City
Country [13] 0 0
China
State/province [13] 0 0
Wuhan
Country [14] 0 0
China
State/province [14] 0 0
Wuxi
Country [15] 0 0
China
State/province [15] 0 0
Xi'an City
Country [16] 0 0
France
State/province [16] 0 0
Creteil
Country [17] 0 0
France
State/province [17] 0 0
Ecully
Country [18] 0 0
France
State/province [18] 0 0
Lyon cedex
Country [19] 0 0
France
State/province [19] 0 0
Marseille
Country [20] 0 0
France
State/province [20] 0 0
Nantes
Country [21] 0 0
France
State/province [21] 0 0
Paris Cedex 19
Country [22] 0 0
France
State/province [22] 0 0
Paris
Country [23] 0 0
France
State/province [23] 0 0
St Cyr Sur Loire
Country [24] 0 0
France
State/province [24] 0 0
Strasbourg
Country [25] 0 0
Germany
State/province [25] 0 0
Freiburg
Country [26] 0 0
Germany
State/province [26] 0 0
Göttingen
Country [27] 0 0
Germany
State/province [27] 0 0
Köln
Country [28] 0 0
Germany
State/province [28] 0 0
München
Country [29] 0 0
Germany
State/province [29] 0 0
Münster
Country [30] 0 0
Germany
State/province [30] 0 0
Sulzbach
Country [31] 0 0
Hong Kong
State/province [31] 0 0
Hong Kong
Country [32] 0 0
Hong Kong
State/province [32] 0 0
Mongkok
Country [33] 0 0
Italy
State/province [33] 0 0
Abruzzo
Country [34] 0 0
Italy
State/province [34] 0 0
Campania
Country [35] 0 0
Italy
State/province [35] 0 0
Lazio
Country [36] 0 0
Italy
State/province [36] 0 0
Lombardia
Country [37] 0 0
Italy
State/province [37] 0 0
Puglia
Country [38] 0 0
Italy
State/province [38] 0 0
Veneto
Country [39] 0 0
Korea, Republic of
State/province [39] 0 0
Daegu
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Seoul
Country [41] 0 0
Poland
State/province [41] 0 0
?ód?
Country [42] 0 0
Poland
State/province [42] 0 0
Bydgoszcz
Country [43] 0 0
Poland
State/province [43] 0 0
Gliwice
Country [44] 0 0
Poland
State/province [44] 0 0
Katowice
Country [45] 0 0
Poland
State/province [45] 0 0
Krakow
Country [46] 0 0
Poland
State/province [46] 0 0
Lublin
Country [47] 0 0
Poland
State/province [47] 0 0
Olsztyn
Country [48] 0 0
Poland
State/province [48] 0 0
Pozna?
Country [49] 0 0
Singapore
State/province [49] 0 0
Singapore
Country [50] 0 0
Spain
State/province [50] 0 0
Madrid
Country [51] 0 0
Spain
State/province [51] 0 0
Navarra
Country [52] 0 0
Spain
State/province [52] 0 0
Cordoba
Country [53] 0 0
Taiwan
State/province [53] 0 0
New Taipei City
Country [54] 0 0
Taiwan
State/province [54] 0 0
Taipei
Country [55] 0 0
Taiwan
State/province [55] 0 0
Zhongzheng Dist.

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: CR44829 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. Only)
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06176352