Study Stopped
Interim Analysis: Optimization of study design required.
Alprostadil in Maculopathy Study (AIMS)
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.
2 other identifiers
interventional
37
1 country
6
Brief Summary
Evaluation of efficacy of alprostadil (prostaglandin E1) for treatment of patients suffering from dry age-related macula degeneration
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2006
Typical duration for phase_3
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 24, 2007
CompletedFirst Posted
Study publicly available on registry
February 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedResults Posted
Study results publicly available
April 11, 2011
CompletedOctober 27, 2014
November 1, 2011
3.6 years
December 24, 2007
January 27, 2011
October 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Difference in visual acuity was measured with the standard ETDRS chart with letters arranged in lines of five. The first line is assumed to have letters of a specific size and each subsequent line to consist of letters of a smaller size. The subject starts reading the first line and continues reading the following lines until failing a line. Passing a line means to name at least three of the five letters correctly.
From baseline to 3 months
Secondary Outcomes (10)
The Difference in Visual Acuity Between Measurements Immediately After Intervention and Measurements at Baseline
From baseline to time immediately after intervention
The Difference in Visual Acuity Between Measurements at 6 Months After Intervention and Measurements at Baseline
From baseline to 6 months
Progression of the Dry Age-related Macular Degeneration
From baseline to 6 months
Development of a Wet Age-related Macular Degeneration
From baseline to 6 months
The Difference in Contrast Sensitivity Between Measurements Immediately After Intervention and Measurements at Baseline
From baseline to time immediately after intervention
- +5 more secondary outcomes
Study Arms (2)
Alprostadil
EXPERIMENTALAlprostadil
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Alprostadil 20 µg ampoules; 60 µg alprostadil/d i.v. for 15 days.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (6)
Unknown Facility
Berlin, Germany
Unknown Facility
Bochum, Germany
Unknown Facility
Dortmund, Germany
Unknown Facility
Karlsruhe, Germany
Unknown Facility
München, Germany
Unknown Facility
Münster, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB Clinical Trial Call Center
- Organization
- UCB
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 24, 2007
First Posted
February 20, 2008
Study Start
July 1, 2006
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
October 27, 2014
Results First Posted
April 11, 2011
Record last verified: 2011-11