Intravitreal Faricimab in Diabetic Macular Edema With Limited Response to Aflibercept

NCT05610488 | Unknown Phase 4

• 1 other identifier: FarDME
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Title: Intravitreal faricimab in diabetic macular edema with limited response to aflibercept Purpose: The purpose of this investigator initiated study is to identify the effects of intravitreal faricimab on recurrence-free treatment intervals and morphological features in diabetic macular edema (DME) in which the Optical coherence tomography (OCT) guided treatment interval failed to be extended to 6 weeks intervals in a treat and extend regimen using aflibercept. Objectives: The primary objective is to evaluate the proportion of patients with an increased maximum treatment interval with intravitreal faricimab (compared to previous 4-week interval under aflibercept) in an OCT guided treat and extend regimen at month 6 and 12. (for further outcome measures see section Objectives)

Conditions

Diabetic Macular Edema

Keywords

DME; poor responder; aflibercept; faricimab

Outcome Measures

Primary Outcomes (1)

• maximum treatment interval with intravitreal faricimab at month 12.

  maximum treatment interval with intravitreal faricimab at month 12.

  12 months

Secondary Outcomes (13)

• BCVA

  12 months

• injection number

  12 months

• metamorphopsia index

  12 months

• CRT (Central retinal thickness)

  12 months

• VFQ-25 Quality of Life Score

  12 months

Study Arms (1)

Vabysmo (Faricimab) 6 mg

EXPERIMENTAL

Vabysmo (Faricimab) 6 mg solution for intravitreal injection All consenting, enrolled patients will receive an intravitreal injection of faricimab 6 mg at baseline (week 0), at week 4, 8, 12 (=4x loading) and each of the following treat and extend visits up to month 12.

Drug: FARICIMAB 6 Mg in 0.05 mL INTRAVITREAL INJECTION, SOLUTION [VABYSMO]

Interventions

FARICIMAB 6 Mg in 0.05 mL INTRAVITREAL INJECTION, SOLUTION [VABYSMO] DRUG

Intravitreal injection of faricimab 6 mg at baseline (week 0), at week 4, 8, 12 (=4x loading) and each of the following treat and extend visits

Also known as: Vabysmo

Vabysmo (Faricimab) 6 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients ≥ 18 years of age and documented diagnosis of diabetes mellitus (Type 1 or Type 2)
• Patients with diagnosis of diabetic macular edema (DME).
• Pre-treatment with intravitreal aflibercept in a treat and extend regimen and failing to be extended from the minimum interval of 4 weeks by two weeks to a 6-weeks interval without recurring DME activity or showing persisting DME activity in all visits under 4-weekly aflibercept treatment for at least 6 months.
• Patients who have a Best corrected Visual Acuity (BCVA) of at least 20/160 (letter score 40 letters) in the study eye using ETDRS (Early Treatment Diabetic Retinopathy Study) charts.
• Willing and able to comply with study procedures.
• For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 3 months after the final dose of study treatment

You may not qualify if:

• Treatment with panretinal photocoagulation or macular laser within 3 months prior to Day 1 to the study eye
• Any intraocular or periocular corticosteroid treatment within 6 months prior to Day 1 to the study eye
• Prior administration of intravitreal faricimab in either eye
• Active intraocular or periocular infection or active intraocular inflammation in the study eye
• Any history of ocular disease other than DME that may confound assessment of the macula/ affect central vision in the study eye
• History of uncontrolled glaucoma in the study eye (intraocular pressure ≥25 mmHg despite anti-glaucoma medication).
• Aphakia with absence of the posterior capsule in the study eye.
• Extracapsular extraction of cataract with phacoemulsification within three months preceding Baseline, or a history of post-operative complications within the last 12 months preceding Baseline in the study eye (uveitis, cyclitis, etc.).
• Use of other investigational drugs at the time of baseline, or within 30 days or 5 half- lives of baseline, whichever is longer (excluding vitamins and minerals).
• Previous violation of the posterior capsule in the study eye unless as a result of laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation.
• Currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable anti-diabetic medication within 3 months prior to Day 1.
• Uncontrolled blood pressure (systolic value \>180 mmHg and/or a diastolic value \>100 mmHg while the patient is at rest)
• Currently pregnant or breastfeeding, or intend to become pregnant during the study.
• History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications.
• History of hypersensitivity or allergy to fluorescein.

Sponsors & Collaborators

• Vista Klinik: lead

MeSH Terms

Interventions

faricimab; Intravitreal Injections; Solutions

Intervention Hierarchy (Ancestors)

Injections, Intraocular; Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Pharmaceutical Preparations

Study Officials

• Katja Hatz, MD

  Vista Augenklinik Binningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judith Buck

CONTACT

0041 61 426 6079; judith.buck@vista.ch

Katja Hatz, MD

CONTACT

0041 61 426 6079; katja.hatz@vista.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of clinical research and medical retina

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 9, 2022
• Study Start: November 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share