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 regime

Phase 1

• Conditions: wet age-related macular degeneration; MedDRA version: 20.0Level: LLTClassification code 10075568Term: Wet age-related macular degenerationSystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2018-003817-16-DE
• Lead Sponsor: Kinarus AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-11
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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

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 < 23 ETDRS letters
7. Concurrent conditions compromising visual acuity requiring medical or surgical intervention
8. Ocular media disturbing imaging (significant vitreous opacity or cataract)
9. Myopia of more than 6 dpt
10. Surgical intraocular intervention within 3 months prior to baseline
11. Patients who are being treated or were treated with pioglitazone or rosiglitazone, immunosuppresants (including oral corticosteroids >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

Study & Design

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