Intravitreal Faricimab in Diabetic Macular Edema With Limited Response to Aflibercept

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vista Klinik

Criteria

Inclusion Criteria:

• 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 give written informed consent according to legal requirements, and who have signed the consent form prior to initiation of any study procedure including withdrawal from exclusionary medications for the purpose of this study.

• 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

Exclusion Criteria:

• 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.

• Inability to obtain Optical Coherence Tomography (OCT), Optical Coherence Tomography Angiography (OCTA), fundus photographs or fluorescein angiograms of sufficient quality.