Alprostadil in Macular Degeneration Study (AIMS) - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00619229

Purpose

Evaluation of efficacy of alprostadil for treatment of patients suffering from age-related macula degeneration

Condition	Intervention	Phase
Macular Degeneration	Drug: Alprostadil Other: Placebo	Phase III

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Alprostadil

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
Official Title:	Confirmatory, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel Groups Study to Assess the Efficacy and Safety of Prostaglandin E-1 in Subjects With Dry Age-Related Macular Degeneration.

Further study details as provided by UCB:

Primary Outcome Measures:

Difference in visual acuity between measurements at 3 months after drug intervention and measurements at baseline [ Time Frame: 3 months ]

Secondary Outcome Measures:

The difference in visual acuity between measurements immediately after interventions as well as at 6 months after intervention and measurements at baseline. [ Time Frame: 6 months ]
Progression of the macular degeneration [ Time Frame: 6 months ]

Estimated Enrollment:	52
Study Start Date:	July 2006
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Alprostadil	Drug: Alprostadil Alprostadil treatment 60 microgram intravenous for 15 days
2: Placebo Comparator Placebo	Other: Placebo Placebo treatment 60 microgram per day intravenous for 15 days

Eligibility

Criteria

Inclusion Criteria:

macular degeneration with hard drusen and with beginning geographic atrophy in one eye
Male and female subjects older than 50 years of age.

Exclusion Criteria:

Glaucoma
Diabetic retinopathy
Uveitis
Medical history of any ophthalmic surgery with complications
Medical history of cataract surgery without complications
Medical history of vitrectomy
AREDS medication
Ophthalmologic dietary supplements
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 > 1.5mg/dL)
Subject has known existing malignant disease
Severe chronic obstructive pulmonary disease
Subject has a veno-occlusive lung disease
Known hepatic disease
Inadequately controlled or untreated hypertension (systolic blood pressure ≥ 180mmHg, diastolic blood pressure ≥110 mmHg
Subject has upper grade cardiac valvular disorders
Pregnancy or lactation period
Known hypersensitivity to Prostaglandin E-1 (PGE-1) 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619229

Contacts

Contact: UCB Clinical Trial Call Center

+1 877 822 9493

Locations

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	SP878
Study First Received:	December 24, 2007
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00619229
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Austria: Agency for Health and Food Safety

Keywords provided by UCB:

Macular Degeneration
Alprostadil
PGE-1

Study placed in the following topic categories:

Alprostadil
Eye Diseases
Retinal Degeneration

Macular Degeneration
Retinal Diseases
Retinal degeneration

Additional relevant MeSH terms:

Vasodilator Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents

Platelet Aggregation Inhibitors
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009