Alprostadil in Maculopathy Study (AIMS)

NCT ID: NCT00619229

Last Updated: 2014-10-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2010-02-28

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.

Conditions

Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Alprostadil

Alprostadil

Group Type: EXPERIMENTAL

Alprostadil (prostaglandin E1)

Intervention Type: DRUG

Alprostadil 20 µg ampoules; 60 µg alprostadil/d i.v. for 15 days.

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo/d i.v. for 15 days

Interventions

Alprostadil (prostaglandin E1)

Alprostadil 20 µg ampoules; 60 µg alprostadil/d i.v. for 15 days.

Intervention Type: DRUG

Placebo

Placebo/d i.v. for 15 days

Intervention Type: OTHER

Other Intervention Names

Prostavasin

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

Berlin, , Germany

Bochum, , Germany

Dortmund, , Germany

Karlsruhe, , Germany

München, , Germany

Münster, , Germany

Countries

Germany

Related Links

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021726s008lbl.pdf

Product Information

Other Identifiers

2005-005686-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SP0878

Identifier Type: -

Identifier Source: org_study_id