A study to test whether BI 764524 helps people with an eye condition called diabetic retinopathy

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Boehringer Ingelheim International GmbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

28 Nov 2024 → ongoing

Decision date (initial)

2024-10-10

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Boehringer Ingelheim International GmbH

External identifiers

EU CT number

2023-508891-12-00

WHO UTN

U1111-1299-0915

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Others, Efficacy, Dose response

The primary objective is to demonstrate a non-flat dosing frequency-response curve and then to evaluate the dosing frequency-response relationship for BI 764524. For this purpose, the response is defined as the proportion of patients with a ≥2-step improvement compared with baseline in Diabetic Retinopathy Severity Scale (DRSS) level in the study eye at Week 52. The treatment effect is summarised as the absolute differences in proportions between BI 764524 and sham.

Secondary objectives 2

1. For the key secondary objective, the response is defined as the proportion of patients developing VTCs, i.e. PDR and/or anterior segment NV, or CI DME, between baseline and Week 52. Like the primary objective, the key secondary objective is to demonstrate a non flat dosing frequency-response curve for this response and then to evaluate the corresponding dosing frequency-response relationship. The treatment effect in regard to the key secondary objective corresponds with the relative risk reduction when comparing BI 764524 to sham.
2. Other secondary objectives are the estimation of treatment differences between BI 764524 and sham for the other secondary efficacy and safety endpoints, separately per BI 764524 dosing regimen.

Conditions and MedDRA coding

Diabetic retinopathy

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed “Document Sharing Agreement”. Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined on the website. Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program. Access Criteria: For study documents – upon signing of a ‚Document Sharing Agreement‘. For study data – 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Male or female, age ≥18 years
2. Diagnosis of diabetes mellitus (DM) under regular treatment with HbA1c <12%; DM should be under regular investigation by a trained specialist as per local standard of care prior to and during the trial
3. Moderate to severe NPDR (DRSS level 43 to 53) as assessed by UWF-CFP images (within the 7 field grid) and confirmed by the CRC at screening.
4. Presence of RNP as assessed by ultra-widefield fluorescein angiography (UWF-FA) defined as ≥12.5 mm² (approximately ≥5 disc areas) within a circular area with a 17.5 mm radius centred to the fovea
5. Visual acuity: BCVA ≥49 letters (ETDRS chart, 4 m distance)
6. Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging

Exclusion criteria 9

1. Active retinal NV within 7 field grid
2. Active NV of iris or in the anterior chamber angle
3. Prior PRP
4. CI-DME, defined as central subfield thickness (CST) ≥320 μm
5. Previous treatment in the study eye for NPDR and/or DME with IVT anti-VEGF (including anti-VEGF/Ang2) or short acting corticosteroid drugs within 6 months prior to Day 1, or >4 treatments within the last 18 months
6. Any previous IVT treatment other than anti-VEGF, and short-acting steroids. Previous dexamethasone IVT drug delivery system (Ozurdex) or fluocinolone acetonide intravitreal implant (Iluvien) is not allowed
7. Active ocular inflammation, aphakia or total absence of the posterior capsule, or uncontrolled glaucoma
8. Refractive error <-8 dioptres
9. Concurrent or past ocular conditions affecting trial results

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the occurrence of a ≥2 step improvement compared with baseline in DRSS level in the study eye at Week 52 as assessed by UWF-CFP images (within the 7-field grid).

Secondary endpoints 9

1. The key secondary endpoint is the occurrence of VTCs, defined as PDR and/or anterior segment NV, or development of CI-DME, in the study eye between baseline and Week 52
2. Absolute change from baseline of BCVA [ETDRS letters] in the study eye at Week 52
3. Absolute change from baseline of central subfield thickness (CST) [μm], as assessed by spectral domain optical coherence tomography (SD-OCT), in the study eye at Week 52
4. Occurrence of a ≥2 step worsening of DRSS in the study eye between baseline and Week 52 as assessed by UWF-CFP images (within the 7-field grid)
5. Occurrence of PDR and/or anterior segment NV in the study eye between baseline and Week 52
6. Occurrence of CI-DME in the study eye between baseline and Week 52
7. Occurrence of drug-related AEs between baseline and EOS
8. Occurrence of ocular AEs in the study eye between baseline and EOS
9. Occurrence of ocular AEs of special interest in the study eye between baseline and EOS

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Boehringer Ingelheim International GmbH

Sponsor organisation

Boehringer Ingelheim International GmbH

Address

Binger Strasse 173

City

Ingelheim Am Rhein

Postcode

55216

Country

Germany

Scientific contact point

Organisation

Boehringer Ingelheim International GmbH

Contact name

CT Disclosure & Data Transparency

Public contact point

Organisation

Boehringer Ingelheim International GmbH

Contact name

CT Disclosure & Data Transparency

Third parties 6

Locations

5 EU/EEA countries · 28 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 81 files

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

Application history

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