Alprostadil in Maculopathy Study (AIMS)

This study has been terminated.
(Interim Analysis: Optimization of study design required.)
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00619229
First received: December 24, 2007
Last updated: August 27, 2014
Last verified: November 2011
  Purpose

Evaluation of efficacy of alprostadil (prostaglandin E1) for treatment of patients suffering from dry age-related macula degeneration


Condition Intervention Phase
Macular Degeneration
Drug: Alprostadil (prostaglandin E1)
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • The Difference in Visual Acuity Between Measurements Immediately After Intervention and Measurements at Baseline [ Time Frame: From baseline to time immediately after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to 6 months ] [ Designated as safety issue: No ]

    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

  • Development of a Wet Age-related Macular Degeneration [ Time Frame: From baseline to 6 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: From baseline to time immediately after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to time immediately after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to 3 months ] [ Designated as safety issue: No ]
    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 6 Months After Intervention and Measurements at Baseline [ Time Frame: From baseline to 6 months ] [ Designated as safety issue: No ]
    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'.


Enrollment: 37
Study Start Date: July 2006
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alprostadil
Alprostadil
Drug: Alprostadil (prostaglandin E1)
Alprostadil 20 µg ampoules; 60 µg alprostadil/d i.v. for 15 days.
Other Name: Prostavasin
Placebo Comparator: Placebo
Placebo
Other: Placebo
Placebo/d i.v. for 15 days

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619229

Locations
Germany
Berlin, Germany
Bochum, Germany
Dortmund, Germany
Karlsruhe, Germany
Muenchen, Germany
Muenster, Germany
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
No publications provided

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00619229     History of Changes
Other Study ID Numbers: SP878, 2005-005686-11
Study First Received: December 24, 2007
Results First Received: January 27, 2011
Last Updated: August 27, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Agency for Health and Food Safety

Keywords provided by UCB Pharma:
Alprostadil
prostaglandin E1
Prostavasin®
macular degeneration

Additional relevant MeSH terms:
Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases
Alprostadil
Cardiovascular Agents
Hematologic Agents
Pharmacologic Actions
Platelet Aggregation Inhibitors
Therapeutic Uses
Urological Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on October 23, 2014