Alprostadil in Maculopathy Study (AIMS)
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Alprostadil (prostaglandin E1); Placebo
Intervention description: Alprostadil 20 µg ampoules; 60 µg alprostadil/d i.v. for 15 days.; Placebo/d i.v. for 15 days
Intervention MeSH terms: Alprostadil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 37.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Alprostadil; prostaglandin E1; Prostavasin®; macular degeneration

Summary:

      Evaluation of efficacy of alprostadil (prostaglandin E1) for treatment of patients suffering
      from dry age-related macula degeneration
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects older than 50 years of age.

          -  Dry age-related macula degeneration (AMD) with hard drusen and possibly beginning
             geographic atrophy in one eye

          -  Visual acuity between 0.2 and 0.7 (logMAR) assessed with ETDRS charts

        Exclusion Criteria:

          -  Dry AMD AREDS category 3 or 4 in both eyes

          -  Wet AMD in at least one eye

          -  Detachment of the pigmentary epithelium

          -  Glaucoma

          -  Diabetic retinopathy

          -  Medical history of retinal vein occlusion

          -  Uveitis

          -  Cataract surgery during the study

          -  High myopia (< -6 dpt) with pathological findings of the retina

          -  Medical history of any opthalmic surgery with complications

          -  Medical history of cataract surgery without complications within the last 12 weeks

          -  Medical history of vitrectomy

          -  AREDS medication within the last 2 days

          -  Opthalmologic dietary supplements within the last 2 days

          -  Medical history of retinal hemorrhage

          -  Cardiac failure (NYHA grade II or higher)

          -  Inadequately controlled coronary heart disease or cardiac arrhythmia

          -  Subject has a medical history and/or suspicion of pulmonary edema or pulmonary
             infiltration

          -  Subject has a peripheral edema

          -  Myocardial infarction within 6 months prior to enrollment

          -  Subject has renal insufficiency, compensated retention (creatinine > 1,5 mg/dL)

          -  Subject has known existing malignant disease

          -  Severe chronic obstructive pulmonary disease

          -  Subject has a venoocclusive lung disease

          -  Known hepatic disease

          -  Inadequately controlled or untreated hypertension (systolic blood pressure ≥ 180 mmHg,
             diastolic blood pressure ≥ 110 mmHg)

          -  Subject has upper grade cardiac valvular disorders

          -  Pregnancy or lactation period

          -  Known hypersensitivity to PGE1 or to any component of the trial medication

          -  Subject has a history of chronic alcohol or drug abuse within the past 2 years

          -  Subject has known lactose intolerance

          -  Poor general state of health or other criteria

          -  Subject has other serious illness

          -  Laboratory values outside the normal range unless considered not clinically relevant
             by the investigator