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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-005686-11 | EudraCT Number |
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Interim Analysis: Optimization of study design required.
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Evaluation of efficacy of alprostadil (prostaglandin E1) for treatment of patients suffering from dry age-related macula degeneration
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alprostadil | Experimental | Alprostadil |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alprostadil (prostaglandin E1) | Drug | Alprostadil 20 µg ampoules; 60 µg alprostadil/d i.v. for 15 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berlin | Germany | |||||
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
| Product Information | View source |
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Participant Flow shows the RS. Baseline Characteristics refer to the FAS.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Alprostadil | Alprostadil 60 mcg/day i.v. for 15 days |
| FG001 | Placebo | Placebo i.v. for 15 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alprostadil | Alprostadil 60 mcg/day i.v. for 15 days |
| BG001 | Placebo | Placebo i.v. for 15 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | 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. | Full Analysis Set (FAS) | Posted | Mean | Standard Deviation | Lines read in ETDRS chart | From baseline to 3 months |
|
Adverse Events (AEs) were collected up to 33 weeks from first dose of trial medication on Day 1 to the last Follow-up Visit.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alprostadil | Alprostadil 60 mcg/day i.v. for 15 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Choroidal Neovascularisation | Eye disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB | + 1 877 822 9493 (UCB) |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000527 | Alprostadil |
| ID | Term |
|---|---|
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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| Placebo | Other | Placebo/d i.v. for 15 days |
|
| From baseline to time immediately after intervention |
| 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. | From baseline to 6 months |
| 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
| From baseline to 6 months |
| 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. | From baseline to 6 months |
| 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. | From baseline to time immediately after intervention |
| 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. | From baseline to 3 months |
| 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. | From baseline to 6 months |
| 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'. | From baseline to time immediately after intervention |
| 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'. | From baseline to 3 months |
| 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'. | From baseline to 6 months |
| Bochum |
| Germany |
| Dortmund | Germany |
| Karlsruhe | Germany |
| München | Germany |
| Münster | Germany |
| Termination of the Study by the Sponsor |
|
| Investigator planned Cataract Operation |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| White | Number | participants |
|
| Weight | Mean | Standard Deviation | kilogramm (kg) |
|
| Height (cm) | Mean | Standard Deviation | centimeter (cm) |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/ (m^2) |
|
| Placebo |
Placebo i.v. for 15 days |
|
|
|
| Secondary | 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. | Full Analysis Set (FAS) | Posted | Mean | Standard Deviation | Lines read in ETDRS chart | From baseline to time immediately after intervention |
|
|
|
| Secondary | 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. | Full Analysis Set (FAS) | Posted | Mean | Standard Deviation | Lines read in ETDRS chart | From baseline to 6 months |
|
|
|
| Secondary | 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
| Full Analysis Set (FAS) | Posted | Number | Participants | From baseline to 6 months |
|
|
|
| Secondary | 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. | Full Analysis Set (FAS) | Posted | Number | Participants | From baseline to 6 months |
|
|
|
| Secondary | 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. | Full Analysis Set (FAS) | Posted | Mean | Standard Deviation | Unit on a scale | From baseline to time immediately after intervention |
|
|
|
| Secondary | 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. | Full Analysis Set (FAS) | Posted | Mean | Standard Deviation | Unit on a scale | From baseline to 3 months |
|
|
|
| Secondary | 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. | Full Analysis Set (FAS) | Posted | Mean | Standard Deviation | Unit on a scale | From baseline to 6 months |
|
|
|
| Secondary | 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'. | Full Analysis Set (FAS) | Posted | Number | Participants | From baseline to time immediately after intervention |
|
|
|
| Secondary | 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'. | Full Analysis Set (FAS) | Posted | Number | Participants | From baseline to 3 months |
|
|
|
| Secondary | 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 Analysis Set (FAS) | Posted | Number | Participants | From baseline to 6 months |
|
|
|
| 0 |
| 18 |
| 2 |
| 18 |
| EG001 | Placebo | Placebo i.v. for 15 days | 0 | 18 | 6 | 18 |
| Visual Disturbance | Eye disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Vitreous Opacities | Eye disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Blood Pressure decreased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
|
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.
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D005229 | Fatty Acids, Monounsaturated |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| Amelioration of disease |
|
| Changed from Pathologic to Normal |
|
| Changed from Pathologic to Normal |
|
| Changed from Pathologic to Normal |
|