Eine 52-wöchige, doppelblinde, randomisierte und placebokontrollierte Studie zur Bewertung der Wirkung der täglichen oralen Gabe von KIN001 150 mg plus Pioglitazon 10 mg auf das Behandlungsintervall in der Standardtherapie bei Patienten mit diagnostizierter einseitiger feuchter altersbedingter Makuladegeneration (AMD)

Product Name: Pioglitazone
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: not available
Other descriptive name: PIOGLITAZONE HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Prolonged-release tablet
Route of administration of the placebo: Oral use

Product Code: KIN001
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PAMAPIMOD
CAS Number: 449811-01-2
Current Sponsor code: KIN001
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Gender:
Female: yes
Male: yes

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