Status:
TERMINATED
Alprostadil in Maculopathy Study (AIMS)
Lead Sponsor:
UCB Pharma
Conditions:
Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
Evaluation of efficacy of alprostadil (prostaglandin E1) for treatment of patients suffering from dry age-related macula degeneration
Detailed Description
Results of the planned interim analysis indicated that the number of originally planned patients were not sufficient to reach statistical significance in the primary end point. Instead of increasing t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00619229
Start Date
July 1 2006
End Date
February 1 2010
Last Update
October 27 2014
Active Locations (6)
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1
Berlin, Germany
2
Bochum, Germany
3
Dortmund, Germany
4
Karlsruhe, Germany