A phase IV study of Faricimab to explore associations of visual acuity benefits and changes in vascular integrity using adaptive optics in patients with diabetic macular edema

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Martin-Luther-Universitaet Halle-Wittenberg

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

1 Sep 2025 → ongoing

Decision date (initial)

2025-06-26

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Roche Pharma AG

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy, Diagnosis

To prove efficacy of Faricimab treatment in BCVA improvement in two different patient populations with diabetic macular edema (in group 1a from baseline to at 12 months and group 1b from baseline
to at 12 months).

Secondary objectives 6

1. To visualize associations of visual acuity benefits and changes in vascular integrity using adaptive optics.
2. Characterization of the efficacy of Faricimab to reduce macular edema and retinal thickness and to enable low frequency of IVIs, respectively.
3. To evaluate treatment intervals during the T&E therapy regimen as number of injections an individual patient in group 1a and group 1b, respectively, has received by 12 months.
4. Significant (p<0.05) reduction of area of the foveal avascular zone (FAZ) of each individual patient from baseline (first visit) to their last visit at 12 months.
5. Characterization of the RPE-PR interface (retinal pigment epithelium - photoreceptor interface) by AO during the study as measured by photoreceptor density (photoreceptor /mm2) of each individual patient from baseline (first visit) to last visit at 12 months.
6. Detailed characterization of diabetes (includes parameters of Ahlqvist classification [11]) and physiological status of each study participant at baseline and at 12 months, that includes BMI, age, sex, smoker, waist to hip ratio, RR, medication, diabetes (Y/N, duration, type), measures of insulin resistance and insulin secretion, HOMA index, blood lipids, HbA1c, time in range (if available or known), serum urine creatinine, CRP, blood cell count, hemoglobin, urine albumin (Reference in Diabetes 2020;69(10):2086-2093)

Conditions and MedDRA coding

Macular edema

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. signed informed consent
2. age ≥18 years, both sexes
3. HbA1c of ≤16%
4. best-corrected visual acuity (BCVA) in the study eye above >25 letters of Early Treatment Diabetic Retinopathy Study (ETDRS) nomenclature (corresponding to 1.2 VAlogMAR)

Exclusion criteria 6

1. Pregnancy or breastfeeding
2. participation in any non-interventional or interventional study
3. previously treated with Faricimab, photodynamic therapy and/or macular laser therapy (photocoagulation)
4. visual acuity below 0.2 VA decimal (equivalent to 0.70 logMAR)
5. glaucoma, intermediate and late age-related macular degeneration, uveitis
6. hypertensive retinopathy stage 3 and 4

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Improvement of visual acuity, measured by change in BCVA (metric variable). BCVA (as measured as letters on the ETDRS chart at a starting distance of 4 m) will be collected from each individual patients of group 1a and group 1b at baseline and at 12 months

Secondary endpoints 7

1. Number of injections during the 12 months therapy on a Q4W, Q8W, Q12W, or Q16W treatment interval at 12 months
2. To evaluate the efficacy of Faricimab on anatomical outcomes using SD-OCT as a clinically relevant parameter for the decision of the treat and extend scheme (T&E). Corresponding secondary endpoints: ● Change from baseline to at 12 months ● absence of DME (CST <325 μm) to at 12 months ● absence of IRF (intra-retinal fluid) to at 12 months ● absence of SRF (sub-retinal fluid) to at 12 months ● absence of IRF and SRF to at 12 months
3. ● Change from baseline in BCVA over time ● gaining ≥10, ≥5, or ≥0 ETDRS letters in BCVA from at baseline to at 12 month ● avoiding a loss of ≥15, ≥10, or ≥5 ETDRS letters in BCVA from at baseline to at 12 month ● gaining ≥15 ETDRS letters from at baseline or achieving BCVA of ≥84 ETDRS letters to at 12 month
4. ● BCVA Snellen equivalent of 20/40 (BCVA ≥69 ETDRS letters) or better to at 12 months ● BCVA Snellen equivalent of 20/200 (BCVA ≤38 ETDRS letters) or worse to at 12 months ● Improved vision measured by Adaptive Sensory Technology (AST) for contrast sensitivity and visual acuity
5. ● longitudinal WLR measurements from at baseline (first visit) to at 12 months) ● gaining WLR >0.1 or >0.5 or <0.1 from at baseline to at 12 month ● Mean WLR at baseline in group 1a significant different from mean WLR at 12 months ● Mean WLR at baseline in group 1b significant different from mean WLR at 12 months
6. ● Change from baseline in FAZ (in µm2) to at 12 months ● >10% reduction of the FAZ to at 12 month
7. Quantification of countable area size in mm2 and photoreceptor density (cones per mm2) by AO at an edema border. ● Change of area size mm2 (focused countable cones per mm2 in a defined retinal area) from baseline to at 12 month ● Change from baseline of photoreceptor density (cones per mm2) to at 12 month

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Martin-Luther-Universitaet Halle-Wittenberg

Sponsor organisation

Martin-Luther-Universitaet Halle-Wittenberg

Address

Ernst-Grube-Strasse 40, Kroellwitz Kroellwitz

City

Halle (Saale)

Postcode

06120

Country

Germany

Scientific contact point

Organisation

Martin-Luther-Universitaet Halle-Wittenberg

Contact name

Prof. Arne Viestenz

Public contact point

Organisation

Martin-Luther-Universitaet Halle-Wittenberg

Contact name

Prof. Arne Viestenz

Locations

1 EU/EEA country · 1 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 21 files

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

Application history

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