A research study to look at how semaglutide compared to placebo affects diabetic eye disease in people with type 2 diabetes (FOCUS)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Novo Nordisk A/S

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

2 May 2019 → ongoing

Decision date (initial)

2024-03-21

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-506827-26-00

EudraCT number

2017-003619-20

WHO UTN

U1111-1201-6256

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

The primary objective is to assess the long-term effects of treatment with semaglutide compared to placebo, both added to standard-of-care, on diabetic retinopathy development and progression in subjects with T2D.

Secondary objectives 5

1. The secondary objectives are to assess the effects of treatment with semaglutide compared to placebo, both added to standard-of-care, with regards to:
2. Visual acuity
3. Diabetic retinopathy manifestations (occurrence of diabetic macular oedema or proliferative diabetic retinopathy)
4. Diabetic retinopathy treatments (laser photocoagulation, intravitreal agents and vitrectomy)
5. Modifiable risk factors for diabetic retinopathy (glycaemia, blood pressure and lipids)

Conditions and MedDRA coding

While it is well-established that long-term good glycaemic control will reduce the risk of diabetic retinopathy development and progression, intensification of glycaemic control has also been associated with an initial worsening of diabetic retinopathy. This phenomenon is known as “early worsening”. The rationale of this trial is to establish the long-term effects of semaglutide on diabetic retinopathy in subjects with type 2 diabetes (T2D) using validated and standardised ophthalmic assessments. This trial is a post-authorisation safety study (PASS) conducted as a commitment to the European Medicines Agency

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Male or female, age ≥18 years at the time of signing informed consent
2. Diagnosed with type 2 diabetes mellitus.
3. HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive).

Exclusion criteria 1

1. NA

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Presence of ≥3 steps ETDRS subject level progression at year 5 (yes/no).

Secondary endpoints 26

1. Time from randomisation to first ≥3 steps ETDRS subject level progression or ciDME in either eye (month).
2. Supportive secondary endpoints
3. Change from baseline at year 5 in:
4. Visual acuity in the worse seeing eye (number of letters)
5. Visual acuity in the better seeing eye (number of letters)
6. Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye during the period from randomisation to year 5 with:
7. Focal/grid laser photocoagulation (yes/no)
8. Pan-retinal laser photocoagulation (yes/no)
9. Intravitreal injection with anti-VEGF (yes/no)
10. Intravitreal injection with steroid (yes/no)
11. Vitrectomy (yes/no)
12. Presence of:
13. ≥3 steps ETDRS subject level improvement at year 5 (yes/no)
14. ≥2 steps ETDRS subject level progression at year 5 (yes/no)
15. ≥2 steps ETDRS subject level improvement at year 5 (yes/no)
16. Persistent visual acuity ≤38 ETDRS letters in either eye at year 5 (yes/no)
17. Persistent ≥2 lines (10 letters) ETDRS worsening in visual acuity in either eye from baseline at year 5 (yes/no
18. Persistent ≥3 lines (15 letters) ETDRS worsening in visual acuity in either eye from baseline at year 5 (yes/no)
19. Persistent ≥2 lines (10 letters) ETDRS improvement in visual acuity in either eye from baseline at year 5 (yes/no)
20. Persistent ≥3 lines (15 letters) ETDRS improvement in visual acuity in either eye from baseline at year 5 (yes/no)
21. ciDME in either eye at year 5 (yes/no)
22. Change from baseline at year 5 in:
23. HbA1c (%-point)
24. Body weight (kg)
25. Systolic and diastolic blood pressure (mmHg)
26. Lipids: Total-cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides (mmol/L)

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novo Nordisk A/S

Sponsor organisation

Novo Nordisk A/S

Address

Novo Alle 1

City

Bagsvaerd

Postcode

2880

Country

Denmark

Scientific contact point

Organisation

Novo Nordisk A/S

Contact name

EU Submission Hub

Public contact point

Organisation

Novo Nordisk A/S

Contact name

EU Submission Hub

Third parties 10

Locations

10 EU/EEA countries · 66 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 85 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