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Alprostadil in Maculopathy Study (AIMS)

This study has been terminated.
(Interim Analysis: Optimization of study design required.)
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00619229
First received: December 24, 2007
Last updated: November 29, 2011
Last verified: November 2011
History of Changes
Results First Received: January 27, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Macular Degeneration
Interventions: Drug: Alprostadil (prostaglandin E1)
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

The Full Analysis Set (FAS) includes all randomized subjects treated with at least one infusion and having valid Baseline and Post-Baseline measurements.

The Randomized Set (RS) consists of all randomized subjects who have completed Visit 16 or terminated prematurely.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participant Flow shows the RS. Baseline Characteristics refer to the FAS.

Reporting Groups
  Description
Alprostadil Alprostadil 60 mcg/day i.v. for 15 days
Placebo Placebo i.v. for 15 days

Participant Flow:   Overall Study
    Alprostadil     Placebo  
STARTED     18     18  
Full Analysis Set (FAS)     16     17  
COMPLETED     14     16  
NOT COMPLETED     4     2  
Withdrawal by Subject                 1                 1  
Lost to Follow-up                 1                 0  
Termination of the Study by the Sponsor                 1                 1  
Investigator planned Cataract Operation                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Alprostadil Alprostadil 60 mcg/day i.v. for 15 days
Placebo Placebo i.v. for 15 days
Total Total of all reporting groups

Baseline Measures
    Alprostadil     Placebo     Total  
Number of Participants  
[units: participants]
 		  16     17     33  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     1     4     5  
>=65 years     15     13     28  
Age  
[units: years]
Mean ± Standard Deviation 		  76.1  ± 8.5     71.7  ± 8.1     73.8  ± 8.5  
Gender  
[units: participants]
 		     
Female     6     9     15  
Male     10     8     18  
White  
[units: participants]
 		  16     17     33  
Weight  
[units: kilogramm (kg)]
Mean ± Standard Deviation 		  77.14  ± 14.71     76.46  ± 14.49     76.79  ± 14.37  
Height (cm)  
[units: centimeter (cm)]
Mean ± Standard Deviation 		  171.06  ± 9.29     168.59  ± 8.69     169.79  ± 8.93  
Body Mass Index (BMI)  
[units: kg/ (m^2)]
Mean ± Standard Deviation 		  26.20  ± 3.38     26.70  ± 3.32     26.45  ± 3.31  



  Outcome Measures
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1.  Primary:   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)   [ Time Frame: From baseline to 3 months ]
  Show Outcome Measure 1

2.  Secondary:   The Difference in Visual Acuity Between Measurements Immediately After Intervention and Measurements at Baseline   [ Time Frame: From baseline to time immediately after intervention ]
  Show Outcome Measure 2

3.  Secondary:   The Difference in Visual Acuity Between Measurements at 6 Months After Intervention and Measurements at Baseline   [ Time Frame: From baseline to 6 months ]
  Show Outcome Measure 3

4.  Secondary:   Progression of the Dry Age-related Macular Degeneration   [ Time Frame: From baseline to 6 months ]
  Show Outcome Measure 4

5.  Secondary:   Development of a Wet Age-related Macular Degeneration   [ Time Frame: From baseline to 6 months ]
  Show Outcome Measure 5

6.  Secondary:   The Difference in Contrast Sensitivity Between Measurements Immediately After Intervention and Measurements at Baseline   [ Time Frame: From baseline to time immediately after intervention ]
  Show Outcome Measure 6

7.  Secondary:   The Difference in Contrast Sensitivity Between Measurements at 3 Months After Intervention and Measurements at Baseline   [ Time Frame: From baseline to 3 months ]
  Show Outcome Measure 7

8.  Secondary:   The Difference in Contrast Sensitivity Between Measurements at 6 Months After Intervention and Measurements at Baseline   [ Time Frame: From baseline to 6 months ]
  Show Outcome Measure 8

9.  Secondary:   The Difference in Color Vision Between Measurements Immediately After Intervention and Measurements at Baseline   [ Time Frame: From baseline to time immediately after intervention ]
  Show Outcome Measure 9

10.  Secondary:   The Difference in Color Vision Between Measurements at 3 Months After Intervention and Measurements at Baseline   [ Time Frame: From baseline to 3 months ]
  Show Outcome Measure 10

11.  Secondary:   The Difference in Color Vision Between Measurements at 6 Months After Intervention and Measurements at Baseline   [ Time Frame: From baseline to 6 months ]
  Show Outcome Measure 11


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
phone: + 1 877 822 9493 (UCB)


No publications provided


Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00619229     History of Changes
Other Study ID Numbers: SP878
Study First Received: December 24, 2007
Results First Received: January 27, 2011
Last Updated: November 29, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Agency for Health and Food Safety