FAME 1 Eye trial

Phase 1

• Conditions: To evaluate the effects of once daily oral fenofibrate compared with placebo on clinically meaningful retinopathy progression over at least 3 years in adults with Type 1 diabetes (T1D) and existing diabetic retinopathy; MedDRA version: 21.1Level: LLTClassification code 10012608Term: Diabetes mellitus insulin-dependentSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2019-002591-14-GB
• Lead Sponsor: Belfast Health & Social Care Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-16
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Participants meeting all of the following criteria will be considered for enrolment into the study:
1) Men or non-pregnant women (on acceptable contraception) with T1D* according to standard criteria;
*T1D defined as either (1) T1D diagnosed below 40 years of age and insulin therapy commencing within one year of T1D diagnosis, or (2) T1D diagnosed before, at or after 40 years of age along with:
i)Documented history of ketoacidosis, and/or
ii)Documented history of very low or undetectable C-peptide (fasting <200 nmol/L or 0.2 pmol/L), and/or
iii)Documented history of T1D related autoantibody/ies (anti-GAD, anti-A2, anti-ZnT8).
2) Age 18 years or over;
3) eGFR must exceed 30 ml/min/1.73m2;
4) Must have at least one eligible eye with non-proliferative retinopathy (ETDRS score 35-53 inclusive) confirmed by current retinal photography within the last 3 months (irrespective of prior laser therapy);
Note: Any eye having undergone prior pan-retinal laser therapy is not eligible, but prior focal, macular or grid laser does not exclude that eye from eligibility.
5) All types of insulin therapy, with no restriction by level of HbA1c;
6) Willing and able to comply with all study requirements, including treatment, assessment and clinic visit attendances;
7) Able to personally read and understand the Participant Information and Consent Form and provide written, signed and dated informed consent to participate in study.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1)Definite indication for or contraindications to fibrate treatment (Other lipid drugs [e.g. statins, ezetimibe, fish oils] are allowed.);
2)Need for bilateral intra-ocular treatment or laser photocoagulation therapy within the next 3 months; (this exclusion only applies to retinal laser photocoagulation treatment onto the posterior pole i.e. laser correction of corneas for short-sightedness is NOT an exclusion criterion);
3)Prior bilateral pan-retinal photocoagulation (PRP) treatment for diabetic retinopathy;
4)Prior bilateral intra-ocular injection(s) within the last 6 months;
5)Bilateral cataract surgery within the last 6 months;
6)Planned bilateral cataract surgery within the next 12 months;
7)History of any other non-diabetic eye disease that is or is likely to affect bilateral vision;
8)History of photosensitive skin rash or myositis;
9)Abnormal thyroid function (untreated);
10)Liver function tests exceeding 3xULN;
11)Persistent elevated unexplained blood CPK level above normal range;
12)Documented fasting TG levels >6.5 mmol/L;
13)History of pancreatitis, DVT or pulmonary embolism;
14)Use of investigational drugs in the prior 8 weeks;
15)Any unstable condition in last 3 months including active sepsis, diabetic ketoacidosis;
16)MI, unstable angina, stroke or heart failure within last 6 months;
17)Diagnosed cancer with ongoing treatment or prognosis anticipated at <5 years;
18)Any obstacle to regular follow-up including scheduled clinic attendances;
19)Prior or planned organ transplantation (including islet cell) with subsequent continued immunosuppression therapy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified