Trial Outcomes & Findings for Alprostadil in Maculopathy Study (AIMS) (NCT NCT00619229)

NCT ID: NCT00619229

Last Updated: 2014-10-27

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 37 participants
• Primary outcome timeframe: From baseline to 3 months
• Results posted on: 2014-10-27

Participant Flow

The Full Analysis Set (FAS) includes all randomized subjects treated with at least one infusion and having valid Baseline and Post-Baseline measurements. The Randomized Set (RS) consists of all randomized subjects who have completed Visit 16 or terminated prematurely.

Participant Flow shows the RS. Baseline Characteristics refer to the FAS.

Participant milestones

Measure	Alprostadil Alprostadil 60 mcg/day i.v. for 15 days	Placebo Placebo i.v. for 15 days
Overall Study STARTED	18	18
Overall Study Full Analysis Set (FAS)	16	17
Overall Study COMPLETED	14	16
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Measure	Alprostadil Alprostadil 60 mcg/day i.v. for 15 days	Placebo Placebo i.v. for 15 days
Overall Study Withdrawal by Subject	1	1
Overall Study Lost to Follow-up	1	0
Overall Study Termination of the Study by the Sponsor	1	1
Overall Study Investigator planned Cataract Operation	1	0

Baseline Characteristics

Alprostadil in Maculopathy Study (AIMS)

Baseline characteristics by cohort

Measure	Alprostadil n=16 Participants Alprostadil 60 mcg/day i.v. for 15 days	Placebo n=17 Participants Placebo i.v. for 15 days	Total n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants	4 Participants n=4 Participants	5 Participants n=27 Participants
Age, Categorical >=65 years	15 Participants n=93 Participants	13 Participants n=4 Participants	28 Participants n=27 Participants
Age, Continuous	76.1 years STANDARD_DEVIATION 8.5 • n=93 Participants	71.7 years STANDARD_DEVIATION 8.1 • n=4 Participants	73.8 years STANDARD_DEVIATION 8.5 • n=27 Participants
Sex: Female, Male Female	6 Participants n=93 Participants	9 Participants n=4 Participants	15 Participants n=27 Participants
Sex: Female, Male Male	10 Participants n=93 Participants	8 Participants n=4 Participants	18 Participants n=27 Participants
White	16 participants n=93 Participants	17 participants n=4 Participants	33 participants n=27 Participants
Weight	77.14 kilogramm (kg) STANDARD_DEVIATION 14.71 • n=93 Participants	76.46 kilogramm (kg) STANDARD_DEVIATION 14.49 • n=4 Participants	76.79 kilogramm (kg) STANDARD_DEVIATION 14.37 • n=27 Participants
Height (cm)	171.06 centimeter (cm) STANDARD_DEVIATION 9.29 • n=93 Participants	168.59 centimeter (cm) STANDARD_DEVIATION 8.69 • n=4 Participants	169.79 centimeter (cm) STANDARD_DEVIATION 8.93 • n=27 Participants
Body Mass Index (BMI)	26.20 kg/ (m^2) STANDARD_DEVIATION 3.38 • n=93 Participants	26.70 kg/ (m^2) STANDARD_DEVIATION 3.32 • n=4 Participants	26.45 kg/ (m^2) STANDARD_DEVIATION 3.31 • n=27 Participants

PRIMARY outcome

Timeframe: From baseline to 3 months

Population: Full Analysis Set (FAS)

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.

Outcome measures

Measure	Alprostadil n=16 Participants Alprostadil 60 mcg/day i.v. for 15 days	Placebo n=17 Participants Placebo i.v. for 15 days
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)	0.94 Lines read in ETDRS chart Standard Deviation 1.84	0.53 Lines read in ETDRS chart Standard Deviation 1.66

SECONDARY outcome

Timeframe: From baseline to time immediately after intervention

Population: Full Analysis Set (FAS)

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.

Outcome measures

Measure	Alprostadil n=16 Participants Alprostadil 60 mcg/day i.v. for 15 days	Placebo n=17 Participants Placebo i.v. for 15 days
The Difference in Visual Acuity Between Measurements Immediately After Intervention and Measurements at Baseline	1.29 Lines read in ETDRS chart Standard Deviation 1.44	0.38 Lines read in ETDRS chart Standard Deviation 1.54

SECONDARY outcome

Timeframe: From baseline to 6 months

Population: Full Analysis Set (FAS)

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.

Outcome measures

Measure	Alprostadil n=16 Participants Alprostadil 60 mcg/day i.v. for 15 days	Placebo n=17 Participants Placebo i.v. for 15 days
The Difference in Visual Acuity Between Measurements at 6 Months After Intervention and Measurements at Baseline	1.31 Lines read in ETDRS chart Standard Deviation 1.45	0.29 Lines read in ETDRS chart Standard Deviation 2.11

SECONDARY outcome

Timeframe: From baseline to 6 months

Population: Full Analysis Set (FAS)

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

Outcome measures

Measure	Alprostadil n=16 Participants Alprostadil 60 mcg/day i.v. for 15 days	Placebo n=17 Participants Placebo i.v. for 15 days
Progression of the Dry Age-related Macular Degeneration Progression in disease	11 Participants	10 Participants
Progression of the Dry Age-related Macular Degeneration Stabilization of disease	1 Participants	3 Participants
Progression of the Dry Age-related Macular Degeneration Amelioration of disease	4 Participants	4 Participants

SECONDARY outcome

Timeframe: From baseline to 6 months

Population: Full Analysis Set (FAS)

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.

Outcome measures

Measure	Alprostadil n=16 Participants Alprostadil 60 mcg/day i.v. for 15 days	Placebo n=17 Participants Placebo i.v. for 15 days
Development of a Wet Age-related Macular Degeneration Yes	0 Participants	0 Participants
Development of a Wet Age-related Macular Degeneration No	16 Participants	17 Participants

SECONDARY outcome

Timeframe: From baseline to time immediately after intervention

Population: Full Analysis Set (FAS)

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.

Outcome measures

Measure	Alprostadil n=16 Participants Alprostadil 60 mcg/day i.v. for 15 days	Placebo n=17 Participants Placebo i.v. for 15 days
The Difference in Contrast Sensitivity Between Measurements Immediately After Intervention and Measurements at Baseline	0.009 Unit on a scale Standard Deviation 0.282	0.018 Unit on a scale Standard Deviation 0.224

SECONDARY outcome

Timeframe: From baseline to 3 months

Population: Full Analysis Set (FAS)

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.

Outcome measures

Measure	Alprostadil n=16 Participants Alprostadil 60 mcg/day i.v. for 15 days	Placebo n=17 Participants Placebo i.v. for 15 days
The Difference in Contrast Sensitivity Between Measurements at 3 Months After Intervention and Measurements at Baseline	0.084 Unit on a scale Standard Deviation 0.205	-0.026 Unit on a scale Standard Deviation 0.324

SECONDARY outcome

Timeframe: From baseline to 6 months

Population: Full Analysis Set (FAS)

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.

Outcome measures

Measure	Alprostadil n=16 Participants Alprostadil 60 mcg/day i.v. for 15 days	Placebo n=17 Participants Placebo i.v. for 15 days
The Difference in Contrast Sensitivity Between Measurements at 6 Months After Intervention and Measurements at Baseline	0.028 Unit on a scale Standard Deviation 0.221	0.009 Unit on a scale Standard Deviation 0.373

SECONDARY outcome

Timeframe: From baseline to time immediately after intervention

Population: Full Analysis Set (FAS)

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'.

Outcome measures

Measure	Alprostadil n=16 Participants Alprostadil 60 mcg/day i.v. for 15 days	Placebo n=17 Participants Placebo i.v. for 15 days
The Difference in Color Vision Between Measurements Immediately After Intervention and Measurements at Baseline Changed from Normal to Pathologic	1 Participants	0 Participants
The Difference in Color Vision Between Measurements Immediately After Intervention and Measurements at Baseline Finding unchanged	15 Participants	13 Participants
The Difference in Color Vision Between Measurements Immediately After Intervention and Measurements at Baseline Changed from Pathologic to Normal	0 Participants	4 Participants

SECONDARY outcome

Timeframe: From baseline to 3 months

Population: Full Analysis Set (FAS)

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'.

Outcome measures

Measure	Alprostadil n=16 Participants Alprostadil 60 mcg/day i.v. for 15 days	Placebo n=17 Participants Placebo i.v. for 15 days
The Difference in Color Vision Between Measurements at 3 Months After Intervention and Measurements at Baseline Changed from Normal to Pathologic	1 Participants	0 Participants
The Difference in Color Vision Between Measurements at 3 Months After Intervention and Measurements at Baseline Finding unchanged	13 Participants	14 Participants
The Difference in Color Vision Between Measurements at 3 Months After Intervention and Measurements at Baseline Changed from Pathologic to Normal	2 Participants	3 Participants

SECONDARY outcome

Timeframe: From baseline to 6 months

Population: Full Analysis Set (FAS)

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'.

Outcome measures

Measure	Alprostadil n=16 Participants Alprostadil 60 mcg/day i.v. for 15 days	Placebo n=17 Participants Placebo i.v. for 15 days
The Difference in Color Vision Between Measurements at 6 Months After Intervention and Measurements at Baseline Changed from Normal to Pathologic	1 Participants	0 Participants
The Difference in Color Vision Between Measurements at 6 Months After Intervention and Measurements at Baseline Finding unchanged	12 Participants	15 Participants
The Difference in Color Vision Between Measurements at 6 Months After Intervention and Measurements at Baseline Changed from Pathologic to Normal	3 Participants	2 Participants

Adverse Events

Alprostadil

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Alprostadil n=18 participants at risk Alprostadil 60 mcg/day i.v. for 15 days	Placebo n=18 participants at risk Placebo i.v. for 15 days
Eye disorders Choroidal Neovascularisation	0.00% 0/18 • Adverse Events (AEs) were collected up to 33 weeks from first dose of trial medication on Day 1 to the last Follow-up Visit. AEs refer to the Safety Set (SS). The SS includes all randomized subjects who completed Visit 16 or terminated prematurely and who received at least one dose of trial medication.	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected up to 33 weeks from first dose of trial medication on Day 1 to the last Follow-up Visit. AEs refer to the Safety Set (SS). The SS includes all randomized subjects who completed Visit 16 or terminated prematurely and who received at least one dose of trial medication.
Eye disorders Visual Disturbance	0.00% 0/18 • Adverse Events (AEs) were collected up to 33 weeks from first dose of trial medication on Day 1 to the last Follow-up Visit. AEs refer to the Safety Set (SS). The SS includes all randomized subjects who completed Visit 16 or terminated prematurely and who received at least one dose of trial medication.	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected up to 33 weeks from first dose of trial medication on Day 1 to the last Follow-up Visit. AEs refer to the Safety Set (SS). The SS includes all randomized subjects who completed Visit 16 or terminated prematurely and who received at least one dose of trial medication.
Eye disorders Vitreous Opacities	0.00% 0/18 • Adverse Events (AEs) were collected up to 33 weeks from first dose of trial medication on Day 1 to the last Follow-up Visit. AEs refer to the Safety Set (SS). The SS includes all randomized subjects who completed Visit 16 or terminated prematurely and who received at least one dose of trial medication.	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected up to 33 weeks from first dose of trial medication on Day 1 to the last Follow-up Visit. AEs refer to the Safety Set (SS). The SS includes all randomized subjects who completed Visit 16 or terminated prematurely and who received at least one dose of trial medication.
Gastrointestinal disorders Nausea	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected up to 33 weeks from first dose of trial medication on Day 1 to the last Follow-up Visit. AEs refer to the Safety Set (SS). The SS includes all randomized subjects who completed Visit 16 or terminated prematurely and who received at least one dose of trial medication.	0.00% 0/18 • Adverse Events (AEs) were collected up to 33 weeks from first dose of trial medication on Day 1 to the last Follow-up Visit. AEs refer to the Safety Set (SS). The SS includes all randomized subjects who completed Visit 16 or terminated prematurely and who received at least one dose of trial medication.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/18 • Adverse Events (AEs) were collected up to 33 weeks from first dose of trial medication on Day 1 to the last Follow-up Visit. AEs refer to the Safety Set (SS). The SS includes all randomized subjects who completed Visit 16 or terminated prematurely and who received at least one dose of trial medication.	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected up to 33 weeks from first dose of trial medication on Day 1 to the last Follow-up Visit. AEs refer to the Safety Set (SS). The SS includes all randomized subjects who completed Visit 16 or terminated prematurely and who received at least one dose of trial medication.
General disorders Fatigue	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected up to 33 weeks from first dose of trial medication on Day 1 to the last Follow-up Visit. AEs refer to the Safety Set (SS). The SS includes all randomized subjects who completed Visit 16 or terminated prematurely and who received at least one dose of trial medication.	0.00% 0/18 • Adverse Events (AEs) were collected up to 33 weeks from first dose of trial medication on Day 1 to the last Follow-up Visit. AEs refer to the Safety Set (SS). The SS includes all randomized subjects who completed Visit 16 or terminated prematurely and who received at least one dose of trial medication.
Infections and infestations Nasopharyngitis	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected up to 33 weeks from first dose of trial medication on Day 1 to the last Follow-up Visit. AEs refer to the Safety Set (SS). The SS includes all randomized subjects who completed Visit 16 or terminated prematurely and who received at least one dose of trial medication.	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected up to 33 weeks from first dose of trial medication on Day 1 to the last Follow-up Visit. AEs refer to the Safety Set (SS). The SS includes all randomized subjects who completed Visit 16 or terminated prematurely and who received at least one dose of trial medication.
Investigations Blood Pressure decreased	0.00% 0/18 • Adverse Events (AEs) were collected up to 33 weeks from first dose of trial medication on Day 1 to the last Follow-up Visit. AEs refer to the Safety Set (SS). The SS includes all randomized subjects who completed Visit 16 or terminated prematurely and who received at least one dose of trial medication.	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected up to 33 weeks from first dose of trial medication on Day 1 to the last Follow-up Visit. AEs refer to the Safety Set (SS). The SS includes all randomized subjects who completed Visit 16 or terminated prematurely and who received at least one dose of trial medication.
Nervous system disorders Dizziness	0.00% 0/18 • Adverse Events (AEs) were collected up to 33 weeks from first dose of trial medication on Day 1 to the last Follow-up Visit. AEs refer to the Safety Set (SS). The SS includes all randomized subjects who completed Visit 16 or terminated prematurely and who received at least one dose of trial medication.	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected up to 33 weeks from first dose of trial medication on Day 1 to the last Follow-up Visit. AEs refer to the Safety Set (SS). The SS includes all randomized subjects who completed Visit 16 or terminated prematurely and who received at least one dose of trial medication.
Nervous system disorders Headache	0.00% 0/18 • Adverse Events (AEs) were collected up to 33 weeks from first dose of trial medication on Day 1 to the last Follow-up Visit. AEs refer to the Safety Set (SS). The SS includes all randomized subjects who completed Visit 16 or terminated prematurely and who received at least one dose of trial medication.	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected up to 33 weeks from first dose of trial medication on Day 1 to the last Follow-up Visit. AEs refer to the Safety Set (SS). The SS includes all randomized subjects who completed Visit 16 or terminated prematurely and who received at least one dose of trial medication.
Nervous system disorders Paraesthesia	0.00% 0/18 • Adverse Events (AEs) were collected up to 33 weeks from first dose of trial medication on Day 1 to the last Follow-up Visit. AEs refer to the Safety Set (SS). The SS includes all randomized subjects who completed Visit 16 or terminated prematurely and who received at least one dose of trial medication.	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected up to 33 weeks from first dose of trial medication on Day 1 to the last Follow-up Visit. AEs refer to the Safety Set (SS). The SS includes all randomized subjects who completed Visit 16 or terminated prematurely and who received at least one dose of trial medication.
Vascular disorders Phlebitis	5.6% 1/18 • Number of events 1 • Adverse Events (AEs) were collected up to 33 weeks from first dose of trial medication on Day 1 to the last Follow-up Visit. AEs refer to the Safety Set (SS). The SS includes all randomized subjects who completed Visit 16 or terminated prematurely and who received at least one dose of trial medication.	0.00% 0/18 • Adverse Events (AEs) were collected up to 33 weeks from first dose of trial medication on Day 1 to the last Follow-up Visit. AEs refer to the Safety Set (SS). The SS includes all randomized subjects who completed Visit 16 or terminated prematurely and who received at least one dose of trial medication.

Additional Information

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