Evaluation of efficacy of alprostadil (prostaglandin E1) for treatment of patients suffering from dry age-related macula degeneration
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
37
Alprostadil 20 µg ampoules; 60 µg alprostadil/d i.v. for 15 days.
Placebo/d i.v. for 15 days
Unnamed facility
Berlin, Germany
Unnamed facility
Bochum, Germany
Unnamed facility
Dortmund, Germany
Unnamed facility
Karlsruhe, Germany
Unnamed facility
München, Germany
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.
Time frame: From baseline to 3 months
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.
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
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.
Time frame: 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 1. Progression 2. Stabilization 3. Amelioration
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Unnamed facility
Münster, Germany
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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'.
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
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'.
Time frame: 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'.
Time frame: From baseline to 6 months