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Trial record 1 of 1 for:    NCT00619229
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Alprostadil in Maculopathy Study (AIMS)

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ClinicalTrials.gov Identifier: NCT00619229
Recruitment Status : Terminated (Interim Analysis: Optimization of study design required.)
First Posted : February 20, 2008
Results First Posted : April 11, 2011
Last Update Posted : October 27, 2014
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Macular Degeneration
Interventions Drug: Alprostadil (prostaglandin E1)
Other: Placebo
Enrollment 37
Recruitment Details

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 Participant Flow shows the RS. Baseline Characteristics refer to the FAS.
Arm/Group Title Alprostadil Placebo
Hide Arm/Group Description Alprostadil 60 mcg/day i.v. for 15 days Placebo i.v. for 15 days
Period Title: Overall Study
Started 18 18
Full Analysis Set (FAS) 16 17
Completed 14 16
Not Completed 4 2
Reason Not Completed
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
Arm/Group Title Alprostadil Placebo Total
Hide Arm/Group Description Alprostadil 60 mcg/day i.v. for 15 days Placebo i.v. for 15 days Total of all reporting groups
Overall Number of Baseline Participants 16 17 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 33 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
   6.3%
4
  23.5%
5
  15.2%
>=65 years
15
  93.8%
13
  76.5%
28
  84.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 17 participants 33 participants
76.1  (8.5) 71.7  (8.1) 73.8  (8.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 33 participants
Female
6
  37.5%
9
  52.9%
15
  45.5%
Male
10
  62.5%
8
  47.1%
18
  54.5%
White  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 33 participants
16 17 33
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogramm (kg)
Number Analyzed 16 participants 17 participants 33 participants
77.14  (14.71) 76.46  (14.49) 76.79  (14.37)
Height (cm)  
Mean (Standard Deviation)
Unit of measure:  Centimeter (cm)
Number Analyzed 16 participants 17 participants 33 participants
171.06  (9.29) 168.59  (8.69) 169.79  (8.93)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/ (m^2)
Number Analyzed 16 participants 17 participants 33 participants
26.20  (3.38) 26.70  (3.32) 26.45  (3.31)
1.Primary Outcome
Title 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)
Hide Description 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.
Time Frame From baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Alprostadil Placebo
Hide Arm/Group Description:
Alprostadil 60 mcg/day i.v. for 15 days
Placebo i.v. for 15 days
Overall Number of Participants Analyzed 16 17
Mean (Standard Deviation)
Unit of Measure: Lines read in ETDRS chart
0.94  (1.84) 0.53  (1.66)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alprostadil, Placebo
Comments

The primary goal of the study was to test the following null hypothesis:

H0: μAlprostadil ≤ μPlacebo, against the alternative hypothesis H1: μAlprostadil > μPlacebo, where μ denotes the mean differences in visual acuity between measurements at 3 months after the end of study drug infusion minus measurements at baseline as assessed as line difference on the standard ETDRS charts.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1220
Comments The criterion for significance (α) was set at one-sided α = 0.025, which means that only an effect in the expected direction was interpreted.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
-0.674 to 2.55
Estimation Comments For exploratory testing an Analysis of Variance-Covariance (ANCOVA) F-test with dependent variable 'difference in visual acuity', fixed factors ‘treatment’ and ‘centre’ and Baseline value as a covariate was used.
2.Secondary Outcome
Title The Difference in Visual Acuity Between Measurements Immediately After Intervention and Measurements at Baseline
Hide Description 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.
Time Frame From baseline to time immediately after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Alprostadil Placebo
Hide Arm/Group Description:
Alprostadil 60 mcg/day i.v. for 15 days
Placebo i.v. for 15 days
Overall Number of Participants Analyzed 16 17
Mean (Standard Deviation)
Unit of Measure: Lines read in ETDRS chart
1.29  (1.44) 0.38  (1.54)
3.Secondary Outcome
Title The Difference in Visual Acuity Between Measurements at 6 Months After Intervention and Measurements at Baseline
Hide Description 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.
Time Frame From baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Alprostadil Placebo
Hide Arm/Group Description:
Alprostadil 60 mcg/day i.v. for 15 days
Placebo i.v. for 15 days
Overall Number of Participants Analyzed 16 17
Mean (Standard Deviation)
Unit of Measure: Lines read in ETDRS chart
1.31  (1.45) 0.29  (2.11)
4.Secondary Outcome
Title Progression of the Dry Age-related Macular Degeneration
Hide Description

Severity of the diagnosed dry age-related macular degeneration (AMD) was assessed in comparison to Baseline and classified as

  1. Progression
  2. Stabilization
  3. Amelioration
Time Frame From baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Alprostadil Placebo
Hide Arm/Group Description:
Alprostadil 60 mcg/day i.v. for 15 days
Placebo i.v. for 15 days
Overall Number of Participants Analyzed 16 17
Measure Type: Number
Unit of Measure: Participants
Progression in disease 11 10
Stabilization of disease 1 3
Amelioration of disease 4 4
5.Secondary Outcome
Title Development of a Wet Age-related Macular Degeneration
Hide Description

A wet age-related macular degeneration (AMD) is defined as the development of choroidal neovascularization of the "study-eye" (worse eye).

Development is categorized in Yes and No, where Yes means that a subject who had no wet AMD at Screening has developed a wet AMD at Week 29.

Time Frame From baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Alprostadil Placebo
Hide Arm/Group Description:
Alprostadil 60 mcg/day i.v. for 15 days
Placebo i.v. for 15 days
Overall Number of Participants Analyzed 16 17
Measure Type: Number
Unit of Measure: Participants
Yes 0 0
No 16 17
6.Secondary Outcome
Title The Difference in Contrast Sensitivity Between Measurements Immediately After Intervention and Measurements at Baseline
Hide Description Difference in contrast sensitivity was measured with the Pelli-Robson test, using a chart with letters arranged in groups of three. The first group has unit contrast and each subsequent group has a lower contrast. Passing a group means to read correctly at least two of the three letters. A Pelli-Robson score of 2.0 indicates normal contrast sensitivity of 100 percent. Scores less than 2.0 signify poorer contrast sensitivity. Pelli-Robson contrast sensitivity score of less than 1.5 is consistent with visual impairment and a score of less than 1.0 represents visual disability.
Time Frame From baseline to time immediately after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Alprostadil Placebo
Hide Arm/Group Description:
Alprostadil 60 mcg/day i.v. for 15 days
Placebo i.v. for 15 days
Overall Number of Participants Analyzed 16 17
Mean (Standard Deviation)
Unit of Measure: Unit on a scale
0.009  (0.282) 0.018  (0.224)
7.Secondary Outcome
Title The Difference in Contrast Sensitivity Between Measurements at 3 Months After Intervention and Measurements at Baseline
Hide Description Difference in contrast sensitivity was measured with the Pelli-Robson test, using a chart with letters arranged in groups of three. The first group has unit contrast and each subsequent group has a lower contrast. Passing a group means to read correctly at least two of the three letters. A Pelli-Robson score of 2.0 indicates normal contrast sensitivity of 100 percent. Scores less than 2.0 signify poorer contrast sensitivity. Pelli-Robson contrast sensitivity score of less than 1.5 is consistent with visual impairment and a score of less than 1.0 represents visual disability.
Time Frame From baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Alprostadil Placebo
Hide Arm/Group Description:
Alprostadil 60 mcg/day i.v. for 15 days
Placebo i.v. for 15 days
Overall Number of Participants Analyzed 16 17
Mean (Standard Deviation)
Unit of Measure: Unit on a scale
0.084  (0.205) -0.026  (0.324)
8.Secondary Outcome
Title The Difference in Contrast Sensitivity Between Measurements at 6 Months After Intervention and Measurements at Baseline
Hide Description Difference in contrast sensitivity was measured with the Pelli-Robson test, using a chart with letters arranged in groups of three. The first group has unit contrast and each subsequent group has a lower contrast. Passing a group means to read correctly at least two of the three letters. A Pelli-Robson score of 2.0 indicates normal contrast sensitivity of 100 percent. Scores less than 2.0 signify poorer contrast sensitivity. Pelli-Robson contrast sensitivity score of less than 1.5 is consistent with visual impairment and a score of less than 1.0 represents visual disability.
Time Frame From baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Alprostadil Placebo
Hide Arm/Group Description:
Alprostadil 60 mcg/day i.v. for 15 days
Placebo i.v. for 15 days
Overall Number of Participants Analyzed 16 17
Mean (Standard Deviation)
Unit of Measure: Unit on a scale
0.028  (0.221) 0.009  (0.373)
9.Secondary Outcome
Title The Difference in Color Vision Between Measurements Immediately After Intervention and Measurements at Baseline
Hide Description The difference in color vision after intervention in comparison to Baseline was assessed by the investigator as 'Changed from Normal to Pathologic', 'Finding unchanged', and 'Changed from Pathologic to Normal'.
Time Frame From baseline to time immediately after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Alprostadil Placebo
Hide Arm/Group Description:
Alprostadil 60 mcg/day i.v. for 15 days
Placebo i.v. for 15 days
Overall Number of Participants Analyzed 16 17
Measure Type: Number
Unit of Measure: Participants
Changed from Normal to Pathologic 1 0
Finding unchanged 15 13
Changed from Pathologic to Normal 0 4
10.Secondary Outcome
Title The Difference in Color Vision Between Measurements at 3 Months After Intervention and Measurements at Baseline
Hide Description The difference in color vision after intervention in comparison to Baseline was assessed by the investigator as 'Changed from Normal to Pathologic', 'Finding unchanged', and 'Changed from Pathologic to Normal'.
Time Frame From baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Alprostadil Placebo
Hide Arm/Group Description:
Alprostadil 60 mcg/day i.v. for 15 days
Placebo i.v. for 15 days
Overall Number of Participants Analyzed 16 17
Measure Type: Number
Unit of Measure: Participants
Changed from Normal to Pathologic 1 0
Finding unchanged 13 14
Changed from Pathologic to Normal 2 3
11.Secondary Outcome
Title The Difference in Color Vision Between Measurements at 6 Months After Intervention and Measurements at Baseline
Hide Description The difference in color vision after intervention in comparison to Baseline was assessed by the investigator as 'Changed from Normal to Pathologic', 'Finding unchanged', and 'Changed from Pathologic to Normal'.
Time Frame From baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Alprostadil Placebo
Hide Arm/Group Description:
Alprostadil 60 mcg/day i.v. for 15 days
Placebo i.v. for 15 days
Overall Number of Participants Analyzed 16 17
Measure Type: Number
Unit of Measure: Participants
Changed from Normal to Pathologic 1 0
Finding unchanged 12 15
Changed from Pathologic to Normal 3 2
Time Frame Adverse Events (AEs) were collected up to 33 weeks from first dose of trial medication on Day 1 to the last Follow-up Visit.
Adverse Event Reporting Description AEs refer to the Safety Set (SS). The SS includes all randomized subjects who completed Visit 16 or terminated prematurely and who received at least one dose of trial medication.
 
Arm/Group Title Alprostadil Placebo
Hide Arm/Group Description Alprostadil 60 mcg/day i.v. for 15 days Placebo i.v. for 15 days
All-Cause Mortality
Alprostadil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Alprostadil Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      0/18 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Alprostadil Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/18 (11.11%)      6/18 (33.33%)    
Eye disorders     
Choroidal Neovascularisation * 1  0/18 (0.00%)  0 1/18 (5.56%)  1
Visual Disturbance * 1  0/18 (0.00%)  0 1/18 (5.56%)  1
Vitreous Opacities * 1  0/18 (0.00%)  0 1/18 (5.56%)  1
Gastrointestinal disorders     
Nausea * 1  1/18 (5.56%)  1 0/18 (0.00%)  0
Abdominal Pain Upper * 1  0/18 (0.00%)  0 1/18 (5.56%)  1
General disorders     
Fatigue * 1  1/18 (5.56%)  1 0/18 (0.00%)  0
Infections and infestations     
Nasopharyngitis * 1  1/18 (5.56%)  1 1/18 (5.56%)  1
Investigations     
Blood Pressure decreased * 1  0/18 (0.00%)  0 1/18 (5.56%)  1
Nervous system disorders     
Dizziness * 1  0/18 (0.00%)  0 1/18 (5.56%)  1
Headache * 1  0/18 (0.00%)  0 1/18 (5.56%)  1
Paraesthesia * 1  0/18 (0.00%)  0 1/18 (5.56%)  1
Vascular disorders     
Phlebitis * 1  1/18 (5.56%)  1 0/18 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
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.
UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
Phone: + 1 877 822 9493 (UCB)
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00619229    
Other Study ID Numbers: SP0878
2005-005686-11 ( EudraCT Number )
First Submitted: December 24, 2007
First Posted: February 20, 2008
Results First Submitted: January 27, 2011
Results First Posted: April 11, 2011
Last Update Posted: October 27, 2014