Trial · NCT00619229
Alprostadil in Maculopathy Study (AIMS)
NCT00619229, Phase 3, Terminated, UCB Pharma; results first posted 2011-04-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Alprostadil in Maculopathy Study (AIMS). Trials, record NCT00619229. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00619229
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Alprostadil in Maculopathy Study (AIMS)
- NCT number
- NCT00619229
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 37 participants, actual
- Lead sponsor
- UCB Pharma
- Conditions
- Macular Degeneration
- Interventions
- Alprostadil (prostaglandin E1), Placebo
- First posted
- 2008-02-20
- Last updated
- 2014-10-27
- Other registries' IDs
- eudract:2005-005686-11
- Results first posted
- 2011-04-11
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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) | From baseline to 3 months | 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 | The Difference in Visual Acuity Between Measurements Immediately After Intervention and Measurements at Baseline | From baseline to time immediately after intervention | 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 | The Difference in Visual Acuity Between Measurements at 6 Months After Intervention and Measurements at Baseline | From baseline to 6 months | 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 | Progression of the Dry Age-related Macular Degeneration | From baseline to 6 months | 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 |
| Secondary | Development of a Wet Age-related Macular Degeneration | From baseline to 6 months | 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. |
| Secondary | The Difference in Contrast Sensitivity Between Measurements Immediately After Intervention and Measurements at Baseline | From baseline to time immediately after intervention | 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. |
| Secondary | The Difference in Contrast Sensitivity Between Measurements at 3 Months After Intervention and Measurements at Baseline | From baseline to 3 months | 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. |
| Secondary | The Difference in Contrast Sensitivity Between Measurements at 6 Months After Intervention and Measurements at Baseline | From baseline to 6 months | 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. |
| Secondary | The Difference in Color Vision Between Measurements Immediately After Intervention and Measurements at Baseline | From baseline to time immediately after intervention | 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'. |
| Secondary | The Difference in Color Vision Between Measurements at 3 Months After Intervention and Measurements at Baseline | From baseline to 3 months | 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'. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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) | From baseline to 3 months | Full Analysis Set (FAS) | Lines read in ETDRS chart | MEAN |
| SECONDARY | The Difference in Visual Acuity Between Measurements Immediately After Intervention and Measurements at Baseline | From baseline to time immediately after intervention | Full Analysis Set (FAS) | Lines read in ETDRS chart | MEAN |
| SECONDARY | The Difference in Visual Acuity Between Measurements at 6 Months After Intervention and Measurements at Baseline | From baseline to 6 months | Full Analysis Set (FAS) | Lines read in ETDRS chart | MEAN |
| SECONDARY | Progression of the Dry Age-related Macular Degeneration | From baseline to 6 months | Full Analysis Set (FAS) | Participants | NUMBER |
| SECONDARY | Development of a Wet Age-related Macular Degeneration | From baseline to 6 months | Full Analysis Set (FAS) | Participants | NUMBER |
| SECONDARY | The Difference in Contrast Sensitivity Between Measurements Immediately After Intervention and Measurements at Baseline | From baseline to time immediately after intervention | Full Analysis Set (FAS) | Unit on a scale | MEAN |
| SECONDARY | The Difference in Contrast Sensitivity Between Measurements at 3 Months After Intervention and Measurements at Baseline | From baseline to 3 months | Full Analysis Set (FAS) | Unit on a scale | MEAN |
| SECONDARY | The Difference in Contrast Sensitivity Between Measurements at 6 Months After Intervention and Measurements at Baseline | From baseline to 6 months | Full Analysis Set (FAS) | Unit on a scale | MEAN |
| SECONDARY | The Difference in Color Vision Between Measurements Immediately After Intervention and Measurements at Baseline | From baseline to time immediately after intervention | Full Analysis Set (FAS) | Participants | NUMBER |
| SECONDARY | The Difference in Color Vision Between Measurements at 3 Months After Intervention and Measurements at Baseline | From baseline to 3 months | Full Analysis Set (FAS) | Participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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) | Alprostadil | 0.94 | Standard Deviation 1.84 | Lines read in ETDRS chart | |
| 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) | Placebo | 0.53 | Standard Deviation 1.66 | Lines read in ETDRS chart | |
| The Difference in Visual Acuity Between Measurements Immediately After Intervention and Measurements at Baseline | Alprostadil | 1.29 | Standard Deviation 1.44 | Lines read in ETDRS chart | |
| The Difference in Visual Acuity Between Measurements Immediately After Intervention and Measurements at Baseline | Placebo | 0.38 | Standard Deviation 1.54 | Lines read in ETDRS chart | |
| The Difference in Visual Acuity Between Measurements at 6 Months After Intervention and Measurements at Baseline | Alprostadil | 1.31 | Standard Deviation 1.45 | Lines read in ETDRS chart | |
| The Difference in Visual Acuity Between Measurements at 6 Months After Intervention and Measurements at Baseline | Placebo | 0.29 | Standard Deviation 2.11 | Lines read in ETDRS chart | |
| Progression of the Dry Age-related Macular Degeneration | Alprostadil | Progression in disease | 11 | Participants | |
| Progression of the Dry Age-related Macular Degeneration | Placebo | Progression in disease | 10 | Participants | |
| Progression of the Dry Age-related Macular Degeneration | Alprostadil | Stabilization of disease | 1 | Participants | |
| Progression of the Dry Age-related Macular Degeneration | Placebo | Stabilization of disease | 3 | Participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Alprostadil | 18 | |
| Overall Study | STARTED | Placebo | 18 | |
| Overall Study | Full Analysis Set (FAS) | Alprostadil | 16 | |
| Overall Study | Full Analysis Set (FAS) | Placebo | 17 | |
| Overall Study | COMPLETED | Alprostadil | 14 | |
| Overall Study | COMPLETED | Placebo | 16 | |
| Overall Study | NOT COMPLETED | Alprostadil | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Choroidal Neovascularisation | Eye disorders | Alprostadil | 0 | 18 | 0 |
| other | Choroidal Neovascularisation | Eye disorders | Placebo | 1 | 18 | 1 |
| other | Visual Disturbance | Eye disorders | Alprostadil | 0 | 18 | 0 |
| other | Visual Disturbance | Eye disorders | Placebo | 1 | 18 | 1 |
| other | Vitreous Opacities | Eye disorders | Alprostadil | 0 | 18 | 0 |
| other | Vitreous Opacities | Eye disorders | Placebo | 1 | 18 | 1 |
| other | Nausea | Gastrointestinal disorders | Alprostadil | 1 | 18 | 1 |
| other | Nausea | Gastrointestinal disorders | Placebo | 0 | 18 | 0 |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Alprostadil | 0 | 18 | 0 |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Placebo | 1 | 18 | 1 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Alprostadil | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Alprostadil | 2 | 18 |
| Total, other adverse events | Placebo | 6 | 18 |
| Total, serious adverse events | Alprostadil | 0 | 18 |
| Total, serious adverse events | Placebo | 0 | 18 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Alprostadil vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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