Back to resultsAlprostadil in Maculopathy Study (AIMS)
Primary Purpose
Macular Degeneration
Status
Terminated
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Alprostadil (prostaglandin E1)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Macular Degeneration focused on measuring Alprostadil, prostaglandin E1, Prostavasin®, macular degeneration
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Alprostadil
Placebo
Arm Description
Alprostadil
Placebo
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The Difference in Visual Acuity Between Measurements Immediately After Intervention and Measurements at Baseline
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.
The Difference in Visual Acuity Between Measurements at 6 Months After Intervention and Measurements at Baseline
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.
Progression of the Dry Age-related Macular Degeneration
Severity of the diagnosed dry age-related macular degeneration (AMD) was assessed in comparison to Baseline and classified as
Progression
Stabilization
Amelioration
Development of a Wet Age-related Macular Degeneration
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.
The Difference in Contrast Sensitivity Between Measurements Immediately After Intervention and Measurements at Baseline
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.
The Difference in Contrast Sensitivity Between Measurements at 3 Months After Intervention and Measurements at Baseline
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.
The Difference in Contrast Sensitivity Between Measurements at 6 Months After Intervention and Measurements at Baseline
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.
The Difference in Color Vision Between Measurements Immediately After Intervention and Measurements at Baseline
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'.
The Difference in Color Vision Between Measurements at 3 Months After Intervention and Measurements at Baseline
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'.
The Difference in Color Vision Between Measurements at 6 Months After Intervention and Measurements at Baseline
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'.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00619229
Brief Title
Alprostadil in Maculopathy Study (AIMS)
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Terminated
Why Stopped
Interim Analysis: Optimization of study design required.
Study Start Date
July 2006 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
Alprostadil, prostaglandin E1, Prostavasin®, macular degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alprostadil
Arm Type
Experimental
Arm Description
Alprostadil
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Alprostadil (prostaglandin E1)
Other Intervention Name(s)
Prostavasin
Intervention Description
Alprostadil 20 µg ampoules; 60 µg alprostadil/d i.v. for 15 days.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo/d i.v. for 15 days
Primary Outcome Measure Information:
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)
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
Secondary Outcome Measure Information:
Title
The Difference in Visual Acuity Between Measurements Immediately After Intervention and Measurements at Baseline
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
Title
The Difference in Visual Acuity Between Measurements at 6 Months After Intervention and Measurements at Baseline
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
Title
Progression of the Dry Age-related Macular Degeneration
Description
Severity of the diagnosed dry age-related macular degeneration (AMD) was assessed in comparison to Baseline and classified as
Progression
Stabilization
Amelioration
Time Frame
From baseline to 6 months
Title
Development of a Wet Age-related Macular Degeneration
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
Title
The Difference in Contrast Sensitivity Between Measurements Immediately After Intervention and Measurements at Baseline
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
Title
The Difference in Contrast Sensitivity Between Measurements at 3 Months After Intervention and Measurements at Baseline
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
Title
The Difference in Contrast Sensitivity Between Measurements at 6 Months After Intervention and Measurements at Baseline
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
Title
The Difference in Color Vision Between Measurements Immediately After Intervention and Measurements at Baseline
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
Title
The Difference in Color Vision Between Measurements at 3 Months After Intervention and Measurements at Baseline
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
Title
The Difference in Color Vision Between Measurements at 6 Months After Intervention and Measurements at Baseline
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
City
Berlin
Country
Germany
City
Bochum
Country
Germany
City
Dortmund
Country
Germany
City
Karlsruhe
Country
Germany
City
Muenchen
Country
Germany
City
Muenster
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021726s008lbl.pdf
Description
Product Information
Learn more about this trial
Alprostadil in Maculopathy Study (AIMS)
We'll reach out to this number within 24 hrs