Patients with dry age-related macular degeneration
Conditions
Interventions
Trade Name: Prostavasin 20 µg
Product Name: Prostavasin 20 µg
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Alprostadil
Concentration unit: µg microgram(s)
Concentration t
Sponsors
SCHWARZ PHARMA Deutschland GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects older than 50 years of age 2. Dry AMD with hard drusen and possibly with beginning geographic atrophy in one eye (if both eyes are affected, the worse eye will be defined as the "study-eye", if the worse eye fulfills AREDS category 3 or 4, the better eye will be defined as the "study-eye") 3. Visual acuity between 0.2 and 0.7 (logMAR) assessed with ETDRS charts 4. Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent. 5. Subject is willing and able to comply with all trial requirements for a total of 7 months. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Ophtalmologic exclusion criteria 1. Dry AMD AREDS category 3 or 4 in both eyes 2. Wet AMD in at least one eye 3. Detachment of the pigmentary epithelium 4. Glaucoma 5. Diabetic retinopathy 6. Medical history of retinal vein occlusion 7. Uveitis 8. Cataract surgery during the study 9. High myopia ( 1.5 mg/dL) 7. Subject has known existing malignant disease 8. Severe chronic obstructive pulmonary disease 9. Subject has a veno-occlusive lung disease 10. Known hepatic disease 11. Inadequately controlled or untreated hypertension (systolic blood pressure = 180 mmHg, diastolic blood pressure = 110 mmHg 12. Subject has upper grade cardiac valvular disorders 13. Pregnancy or lactation period 14. Known hypersensitivity to PGE1 or to any component of the trial medication 15. Subject has a history of chronic alcohol or drug abuse within the past 2 years 16. Subject has known lactose intolerance 17. Poor general state of health or other criteria preventing the subject from complying with the study procedures 18. Subject has other serious illness of the patient that the investigator considers to compromise his/her participation in the trial 19. Laboratory values outside the normal range unless considered not clinically relevant by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective of this study is to show a superior effect of Prostavasin® compared to placebo on visual acuity in subjects with a dry AMD at 3 months after the end of study drug infusion.;Secondary Objective: Secondary objectives are to show a superior effect of Prostavasin® compared to placebo on visual acuity immediately after and at 6 months after the end of study drug infusion. Furthermore, a superior effect of Prostavasin® on progression of the dry and on development of a wet AMD as well as on contrast sensitivity and color vision shall be demonstrated. The safety of Prostavasin® infusion will be investigated by means of adverse events, laboratory values, vital signs and ECG at rest.;Primary end point(s): Primary efficacy variable is the difference in visual acuity between measurements at 3 months after the end of study drug infusion and measurements at baseline, which will be assessed as difference in lines with ETDRS. | — |
Countries
Austria, Germany
Outcome results
None listed