Alprostadil in Maculopathy Study (AIMS)

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

Study Overview

• Status: Terminated
• Conditions: Macular Degeneration
• Intervention / Treatment: Drug: Alprostadil (prostaglandin E1); Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
  • Bochum, Germany
  • Dortmund, Germany
  • Karlsruhe, Germany
  • Muenchen, Germany
  • Muenster, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Other: Placebo; Placebo/d i.v. for 15 days
EXPERIMENTAL: Alprostadil	Drug: Alprostadil (prostaglandin E1); Alprostadil 20 µg ampoules; 60 µg alprostadil/d i.v. for 15 days.; Other Names: Prostavasin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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; Progression; Stabilization; Amelioration	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

Collaborators and Investigators

• Sponsor: UCB Pharma

Publications and helpful links

Helpful Links

• FDA Safety Alerts and Recalls
• Product Information

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (ACTUAL): February 1, 2010
• Study Completion (ACTUAL): February 1, 2010

Study Registration Dates

• First Submitted: December 24, 2007
• First Submitted That Met QC Criteria: February 8, 2008
• First Posted (ESTIMATE): February 20, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): October 27, 2014
• Last Update Submitted That Met QC Criteria: October 17, 2014
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: macular degeneration; prostaglandin E1; Alprostadil; Prostavasin®
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Vasodilator Agents; Urological Agents; Platelet Aggregation Inhibitors; Alprostadil
• Other Study ID Numbers: SP0878; 2005-005686-11 (EUDRACT_NUMBER)