Clinical trial NCT00619229: Alprostadil in Maculopathy Study (AIMS)
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Macular Degeneration
Keywords: Alprostadil
prostaglandin E1
Prostavasin®
macular degeneration
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2008-02-20
Enrollment: 37
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 the sample size accordingly, it was decided to terminate the study and plan future proceedings based on a careful analysis of the unblinded results.

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

Primary outcomes:
measure: Difference in Visual Acuity Between Measurements at 3 Months After Drug Intervention and Measurements at Baseline (Assessed Within Early Treatment Diabetic Retinopathy Study (ETDRS) Chart)
timeFrame: From baseline to 3 months
Secondary outcomes:
measure: The Difference in Visual Acuity Between Measurements Immediately After Intervention and Measurements at Baseline
timeFrame: From baseline to time immediately after intervention
measure: The Difference in Visual Acuity Between Measurements at 6 Months After Intervention and Measurements at Baseline
timeFrame: From baseline to 6 months
measure: Progression of the Dry Age-related Macular Degeneration
timeFrame: From baseline to 6 months
measure: Development of a Wet Age-related Macular Degeneration
timeFrame: From baseline to 6 months
measure: The Difference in Contrast Sensitivity Between Measurements Immediately After Intervention and Measurements at Baseline
timeFrame: From baseline to time immediately after intervention
measure: The Difference in Contrast Sensitivity Between Measurements at 3 Months After Intervention and Measurements at Baseline
timeFrame: From baseline to 3 months
measure: The Difference in Contrast Sensitivity Between Measurements at 6 Months After Intervention and Measurements at Baseline
timeFrame: From baseline to 6 months
measure: The Difference in Color Vision Between Measurements Immediately After Intervention and Measurements at Baseline
timeFrame: From baseline to time immediately after intervention
measure: The Difference in Color Vision Between Measurements at 3 Months After Intervention and Measurements at Baseline
timeFrame: From baseline to 3 months
measure: The Difference in Color Vision Between Measurements at 6 Months After Intervention and Measurements at Baseline
timeFrame: From baseline to 6 months
Other outcomes:
Locations:
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Dortmund
country: Germany
city: Karlsruhe
country: Germany
city: Muenchen
country: Germany
city: Muenster
country: Germany
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: