A 52 weeks double blind, randomized and placebo controlled trial evaluating the effect of oral KIN001 150 mg plus pioglitazone 10 mg daily on injection frequency of Standard of Care in patients with diagnosed unilateral wet AMD undergoing a treat and extend regimen

A 52 weeks double blind, randomized and placebo controlled trial evaluating the effect of oral KIN001 150 mg plus pioglitazone 10 mg daily on injection frequency of Standard of Care in patients with diagnosed unilateral wet AMD undergoing a treat and extend regimen - Kinarus wet AMD treat and extend study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003817-16-DE

Enrollment

100

Registered

2018-12-11

Start date

2019-04-04

Completion date

Unknown

Last updated

2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

wet age-related macular degeneration MedDRA version: 20.0 Level: LLT Classification code 10075568 Term: Wet age-related macular degeneration System Organ Class: 100000004853

Interventions

Product Name: Pioglitazone Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: not available Other descriptive name: PIOGLITAZONE HYDROCHLORIDE Concentration unit: mg milligram(s) Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female patients with confirmed diagnosis of unilateral wet AMD 2. Patients on SOC treatment for at least 9 months having failed two attempts to extend to a 6-week treatment interval, where failure is defined as having at least one of the following signs of disease activity of the choroidal neovascularization after the 6 week interval a. Recurrent or new intra- or subretinal fluid b. New macular haemorrhage c. New choroidal neovascularization 3. Patients with Type III choroidal neovascular/retinal angiomatous proliferating (RAP) lesions are allowed for participation in the study. Randomization will be stratified. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80

Exclusion criteria

Exclusion criteria: 1. Patients = 50 years of age 2. Advanced fibrosis (more than 50% of the total lesion size on fluorescein angiography) 3. Fibrosis affecting the fovea as defined by SD-OCT 4. Subretinal hemorrhage of ?50% of the lesion area and atrophy 5. Retinal pigment epithelium rupture 6. BCVA letter score 7.5mg/day) or gemfibrozil and rifampicin within 4 weeks prior randomization 12. Patients where oral administration of pioglitazone is contraindicated (i.e. cardiac failure or history of cardiac failure (NYHA stages I to IV), hepatic impairment, diabetic ketoacidosis, current bladder cancer or a history of bladder cancer, uninvestigated macroscopic haematuria 13. Any severe, progressive or uncontrolled medical condition at baseline that in the judgment of the investigator prevents the patient from participating in the study 14. Patients treated with insulin secretagogues 15. Patients with known hypersensitivities to the active substance or any of the ingredients 16. Any clinically significant abnormal laboratory tests at screening 17. Any other investigational treatment for wet AMD in the last 3 months prior to baseline

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary Objectives: • To assess the safety and tolerability of oral KIN001 150 mg plus pioglitazone 10 mg daily when given in conjuction with SOC treat and extend regimen in patients with diagnosed unilateral wet AMD • To assess the effect of oral KIN001 150 mg plus pioglitazone 10 mg daily on proportion of patients who achieve a successful and confirmed extension of the injection interval of SOC at end of study in patients with diagnosed unilateral wet AMD undergoing a treat and extend regimen (TER) ;Secondary Objective: The secondary objectives for this study are: • To assess the pharmacokinetics of oral KIN001 • To assess the effect of oral KIN001 150 mg plus pioglitazone 10 mg daily o on visual acuity o on retinal morphology and function o on patient quality of life;Primary end point(s): Proportion of patients who achieve a successful and confirmed extension of the injection interval of SOC at end treatment;Timepoint(s) of evaluation of this end point: 52 weeks	—

Measure

Time frame

Main Objective: Primary Objectives: • To assess the safety and tolerability of oral KIN001 150 mg plus pioglitazone 10 mg daily when given in conjuction with SOC treat and extend regimen in patients with diagnosed unilateral wet AMD • To assess the effect of oral KIN001 150 mg plus pioglitazone 10 mg daily on proportion of patients who achieve a successful and confirmed extension of the injection interval of SOC at end of study in patients with diagnosed unilateral wet AMD undergoing a treat and extend regimen (TER) ;Secondary Objective: The secondary objectives for this study are: • To assess the pharmacokinetics of oral KIN001 • To assess the effect of oral KIN001 150 mg plus pioglitazone 10 mg daily o on visual acuity o on retinal morphology and function o on patient quality of life;Primary end point(s): Proportion of patients who achieve a successful and confirmed extension of the injection interval of SOC at end treatment;Timepoint(s) of evaluation of this end point: 52 weeks

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Secondary

Measure	Time frame
Secondary end point(s): • number of injections of SOC at end of treatment • proportion of patients who achieve a successful and confirmed extension interval to 8 weeks and above • length of the successful interval extension - length of the achieved successful interval extension at end of treatment for each patient • number of interval extensions and number of interval reductions per patient • time to successful extension per patient and per cohort • maximum recurrence-free treatment interval • best corrected visual acuity (BCVA) at end of treatment for both the SOC-treated and the fellow eye • central retinal thickness (CRT) change from baseline at end of treatment for both the SOC-treated and the fellow eye • detailed morphological features as assessed by OCT and FA at end of treatment and at timepoints during the extension phase for both the SOC treated and the fellow eye • proportion of patients at each score difference between baseline and end of treatment in the NEI-VFQ-25;Timepoint(s) of evaluation of this end point: 52 weeks	—

Measure

Time frame

Secondary end point(s): • number of injections of SOC at end of treatment • proportion of patients who achieve a successful and confirmed extension interval to 8 weeks and above • length of the successful interval extension - length of the achieved successful interval extension at end of treatment for each patient • number of interval extensions and number of interval reductions per patient • time to successful extension per patient and per cohort • maximum recurrence-free treatment interval • best corrected visual acuity (BCVA) at end of treatment for both the SOC-treated and the fellow eye • central retinal thickness (CRT) change from baseline at end of treatment for both the SOC-treated and the fellow eye • detailed morphological features as assessed by OCT and FA at end of treatment and at timepoints during the extension phase for both the SOC treated and the fellow eye • proportion of patients at each score difference between baseline and end of treatment in the NEI-VFQ-25;Timepoint(s) of evaluation of this end point: 52 weeks

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Countries

Germany, Switzerland

Contacts

Public ContactHead Clinical Operations

Kinarus AG

corinne.peter@kinarus.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026