Alprostadil in Maculopathy Study (AIMS)

Phase 3

Terminated

• Conditions: Macular Degeneration
• Interventions: Drug: Alprostadil (prostaglandin E1); Other: Placebo

• Registration Number: NCT00619229
• Lead Sponsor: UCB Pharma

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.

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2007-12-24
• Study First Submitted QC: 2008-02-08
• Study First Posted: 2008-02-20
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Results First Submitted: 2011-01-27
• Results First Submitted QC: 2011-03-10
• Results First Posted: 2011-04-11
• Status Verified: 2011-11
• Last Update Submitted: 2014-10-17
• Last Update Posted: 2014-10-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alprostadil	Alprostadil (prostaglandin E1)	Alprostadil
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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
The Difference in Color Vision Between Measurements at 6 Months After Intervention and Measurements at Baseline	From baseline to 6 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'.
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.
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.
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.
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.
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'.
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'.