Macular DegenerationPhase 3NCT00619229
Alprostadil in Maculopathy Study (AIMS)
A Phase 3 study testing Alprostadil (prostaglandin E1) in people with Macular Degeneration, run by UCB Pharma at 6 sites in Germany.
Trial summary
Evaluation of efficacy of alprostadil (prostaglandin E1) for treatment of patients suffering from dry age-related macula degeneration Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- Alprostadil (prostaglandin E1)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 6 sitesGermany
- Study dates
- Jul 2006to Feb 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 34Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Study site
Berlin
Study site
Bochum
Study site
Dortmund
Study site
Karlsruhe
Study site
München
Study site
Münster
About this study
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.
Evaluation of efficacy of alprostadil (prostaglandin E1) for treatment of patients suffering from dry age-related macula degeneration
Read the 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.
- Conditions
- Macular Degeneration
- Being tested
- Alprostadil (prostaglandin E1), Placebo
- Keywords
- Alprostadil, prostaglandin E1, Prostavasin®, macular degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alprostadil (prostaglandin E1)Drug
Also called Prostavasin
Alprostadil 20 µg ampoules; 60 µg alprostadil/d i.v. for 15 days.
PlaceboOther
Placebo/d i.v. for 15 days
| Study group | Role | What they receive |
|---|---|---|
| Alprostadil | Experimental | Alprostadil Receives: Drug: Alprostadil (prostaglandin E1) |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 3 months
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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
- Progression
- Stabilization
- Amelioration
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: From baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startJul 2006
- Primary completionFeb 2010
- Study completionFeb 2010
Why it stopped: Interim Analysis: Optimization of study design required.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619229
- Sponsor's protocol ID
- SP0878
- Other IDs
- 2005-005686-11, 2005
- Status last verified
- Nov 2011
- First submitted
- 24 Dec 2007
- Last updated
- 27 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00619229
- Acronym / sponsor ID
- SP0878
- Conditions
- Macular Degeneration
- Keywords
- Alprostadil, prostaglandin E1, Prostavasin®, macular degeneration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim Analysis: Optimization of study design required.
- Enrolment
- 37 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 20 Feb 2008 (estimated)
- Results
- Posted 11 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alprostadil | Experimental | Drug: Alprostadil (prostaglandin E1)Alprostadil |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (34 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alprostadil (prostaglandin E1)Also: ProstavasinAlprostadil 20 µg ampoules; 60 µg alprostadil/d i.v. for 15 days. | Drug | Alprostadil |
| PlaceboPlacebo/d i.v. for 15 days | Other | Placebo |
Primary outcome
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
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.
10 secondary outcomes
The Difference in Visual Acuity Between Measurements Immediately After Intervention and Measurements at Baseline
Time frame: From baseline to time immediately after intervention
The Difference in Visual Acuity Between Measurements at 6 Months After Intervention and Measurements at Baseline
Time frame: From baseline to 6 months
Progression of the Dry Age-related Macular Degeneration
Time frame: From baseline to 6 months
Development of a Wet Age-related Macular Degeneration
Time frame: From baseline to 6 months
The Difference in Contrast Sensitivity Between Measurements Immediately After Intervention and Measurements at Baseline
Time frame: From baseline to time immediately after intervention
The Difference in Contrast Sensitivity Between Measurements at 3 Months After Intervention and Measurements at Baseline
Time frame: From baseline to 3 months
The Difference in Contrast Sensitivity Between Measurements at 6 Months After Intervention and Measurements at Baseline
Time frame: From baseline to 6 months
The Difference in Color Vision Between Measurements Immediately After Intervention and Measurements at Baseline
Time frame: From baseline to time immediately after intervention
The Difference in Color Vision Between Measurements at 3 Months After Intervention and Measurements at Baseline
Time frame: From baseline to 3 months
The Difference in Color Vision Between Measurements at 6 Months After Intervention and Measurements at Baseline
Time frame: From baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Product InformationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alprostadil (prostaglandin E1) in people with Macular Degeneration, run by UCB Pharma at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2014.