CONFIRMATORY, PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUPS STUDY TO ASSESS THE EFFICACY AND SAFETY OF PROSTAGLANDIN E1 IN SUBJECTS WITH DRY AGE-RELATED MACULAR DEGENERATION - AIMS
- Conditions
- Patients with dry age-related macular degeneration
- Registration Number
- EUCTR2005-005686-11-DE
- Lead Sponsor
- SCHWARZ PHARMA Deutschland GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
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
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 (< –6 dpt) with pathological findings of the retina
10. Medical history of any ophthalmic surgery with complications
11. Medical history of cataract surgery without complications within the last 12 weeks
12. Medical history of vitrectomy
13. AREDS medication (vitamin C, beta-carotene, zinc and copper) within the last 2 days
14. Ophthalmologic dietary supplements within the last 2 days
15. Medical history of retinal hemorrhage.
Internal medical exclusion criteria:
1. Inadequately controlled cardiac failure (NYHA grade III and IV), coronary heart disease or cardiac arrhythmia
2. Subject has a medical history and / or suspicion of pulmonary edema or pulmonary infiltration
3. Myocardial infarction within 6 months prior to enrollment in this study
4. Subject has renal insufficiency, compensated retention (creatinine > 2.0 mg/dL)
5. Subject has known existing malignant disease
6. Severe chronic obstructive pulmonary disease
7. Subject has a veno-occlusive lung disease
8. Known hepatic disease
9. Inadequately controlled or untreated hypertension (systolic blood pressure = 180 mmHg, diastolic blood pressure = 110 mmHg
10. Subject has upper grade cardiac valvular disorders
11. Pregnancy or lactation period
12. Known hypersensitivity to PGE1 or to any component of the trial medication
13. Subject has a history of chronic alcohol or drug abuse within the past 2 years
14. Subject has known lactose intolerance
15. Poor general state of health or other criteria preventing the subject from complying with the study procedures
16. Subject has other serious illness of the patient that the investigator considers to compromise his/her participation in the trial
17. Laboratory values outside the normal range unless considered not clinically relevant by the investigator.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br><br>
- Secondary Outcome Measures
Name Time Method