Trial Outcomes & Findings for Use of Immune Globulin Intravenous (Human) To Treat Age-Related Macular Degeneration (NCT NCT00220805)
NCT ID: NCT00220805
Last Updated: 2016-03-21
Results Overview
Using the LogMAR score, lower values correspond to higher visual acuity. For example, a visual acuity of 20/20 corresponds to a LogMAR value of zero (0), and a visual acuity of 20/100 corresponds to a LogMAR value of 0.7.
COMPLETED
PHASE2
96 participants
At Week 12 or, if the Week 12 assessment is not available, at the last LogMAR assessment conducted at or after Week 8 of the Treatment Period
2016-03-21
Participant Flow
A total of 96 subjects were enrolled (signed the informed consent and screened) in this study at 6 German study centers.
Of the 96 enrolled subjects, 14 subjects withdrew their consent for participation before randomization and an additional 25 subjects were withdrawn before randomization because of violations of inclusion/exclusion criteria or because their angiograms were rejected by the central reading site as not meeting the pre-specified criteria.
Participant milestones
| Measure |
IGIV-C 10%
Immune Globulin Intravenous \[Human\], 10% Caprylate/Chromatography Purified
|
Placebo
Albumin (Human) 25%, United States Pharmacopeia (USP)
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
27
|
|
Overall Study
COMPLETED
|
22
|
16
|
|
Overall Study
NOT COMPLETED
|
8
|
11
|
Reasons for withdrawal
| Measure |
IGIV-C 10%
Immune Globulin Intravenous \[Human\], 10% Caprylate/Chromatography Purified
|
Placebo
Albumin (Human) 25%, United States Pharmacopeia (USP)
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Develop. of choroidal neovascularization
|
3
|
8
|
Baseline Characteristics
Use of Immune Globulin Intravenous (Human) To Treat Age-Related Macular Degeneration
Baseline characteristics by cohort
| Measure |
IGIV-C 10%
n=29 Participants
Immune Globulin Intravenous \[Human\], 10% Caprylate/Chromatography Purified
|
Placebo
n=24 Participants
Albumin (Human) 25%, United States Pharmacopeia (USP)
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Age, Continuous
|
74.724 years
STANDARD_DEVIATION 8.417 • n=5 Participants
|
74.042 years
STANDARD_DEVIATION 10.217 • n=7 Participants
|
74.415 years
STANDARD_DEVIATION 9.189 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
29 participants
n=5 Participants
|
24 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Visual Acuity Score (VAS) of the Study Eyes
|
55.9 units on a scale
STANDARD_DEVIATION 10.4 • n=5 Participants
|
58.4 units on a scale
STANDARD_DEVIATION 7.7 • n=7 Participants
|
57.0 units on a scale
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Logarithm of the Minimum Angle of Resolution (LogMAR) of the Study Eyes
|
0.581 LogMAR
STANDARD_DEVIATION 0.209 • n=5 Participants
|
0.533 LogMAR
STANDARD_DEVIATION 0.153 • n=7 Participants
|
0.559 LogMAR
STANDARD_DEVIATION 0.186 • n=5 Participants
|
PRIMARY outcome
Timeframe: At Week 12 or, if the Week 12 assessment is not available, at the last LogMAR assessment conducted at or after Week 8 of the Treatment PeriodPopulation: The Intent-to-Treat (ITT) Population consisted of all randomized subjects who received any amount of study medication and had at least one evaluation of the primary efficacy variable (LogMAR score) at Week 8 or later and at Baseline.
Using the LogMAR score, lower values correspond to higher visual acuity. For example, a visual acuity of 20/20 corresponds to a LogMAR value of zero (0), and a visual acuity of 20/100 corresponds to a LogMAR value of 0.7.
Outcome measures
| Measure |
IGIV-C 10%
n=29 Participants
Immune Globulin Intravenous \[Human\], 10% Caprylate/Chromatography Purified
|
Placebo
n=24 Participants
Albumin (Human) 25%, United States Pharmacopeia (USP)
|
|---|---|---|
|
Mean Change in Visual Acuity (Logarithm of the Minimum Angle of Resolution [LogMAR]) Score From Baseline for IGIV-C, 10% Compared to Placebo at Week 12 or at Last LogMAR Assessment (Conducted at or After Week 8 of the Treatment Period)
Baseline
|
0.581 LogMAR
Standard Deviation 0.209
|
0.533 LogMAR
Standard Deviation 0.153
|
|
Mean Change in Visual Acuity (Logarithm of the Minimum Angle of Resolution [LogMAR]) Score From Baseline for IGIV-C, 10% Compared to Placebo at Week 12 or at Last LogMAR Assessment (Conducted at or After Week 8 of the Treatment Period)
End of treatment (EOT) Week 12 or last assessment
|
0.646 LogMAR
Standard Deviation 0.309
|
0.557 LogMAR
Standard Deviation 0.244
|
|
Mean Change in Visual Acuity (Logarithm of the Minimum Angle of Resolution [LogMAR]) Score From Baseline for IGIV-C, 10% Compared to Placebo at Week 12 or at Last LogMAR Assessment (Conducted at or After Week 8 of the Treatment Period)
Change End of treatment (EOT) minus Baseline
|
0.064 LogMAR
Standard Deviation 0.220
|
0.024 LogMAR
Standard Deviation 0.182
|
SECONDARY outcome
Timeframe: Last measurement at or later than Week 8Population: Intent to Treat
Outcome measures
| Measure |
IGIV-C 10%
n=29 Participants
Immune Globulin Intravenous \[Human\], 10% Caprylate/Chromatography Purified
|
Placebo
n=24 Participants
Albumin (Human) 25%, United States Pharmacopeia (USP)
|
|---|---|---|
|
Proportion of Subjects Who Improve Visual Acuity From Baseline to Endpoint by ≥ 0.1 LogMAR
|
24.1 percentage of participants
|
20.8 percentage of participants
|
SECONDARY outcome
Timeframe: Last measurement at or later than Week 8Population: Intent to Treat
Outcome measures
| Measure |
IGIV-C 10%
n=29 Participants
Immune Globulin Intravenous \[Human\], 10% Caprylate/Chromatography Purified
|
Placebo
n=24 Participants
Albumin (Human) 25%, United States Pharmacopeia (USP)
|
|---|---|---|
|
Proportion of Subjects Who Improve Visual Acuity From Baseline to Endpoint by ≥ 0.2 LogMAR
|
3.4 percentage of participants
|
16.7 percentage of participants
|
SECONDARY outcome
Timeframe: Last measurement at or later than Week 8Population: Intent to Treat
The RADNER test gives not only information about the subject's reading performance, but also about the reading speed (life quality) and the faults while reading. The RADNER reading charts (1, 2, and 3) contain sentences in paragraphs having a range of print sizes starting with the largest print at the top.The subject was randomly assigned one of the RADNER charts, and the charts were different between consecutive visits. The reading distance was 25 cm. The subject's score was corrected for reading speed and errors. The range of possible logRAD scores was from 2.0 (could not read the first paragraph) to -0.2, with higher scores indicating lower reading acuity and lower scores indicating higher reading acuity.
Outcome measures
| Measure |
IGIV-C 10%
n=29 Participants
Immune Globulin Intravenous \[Human\], 10% Caprylate/Chromatography Purified
|
Placebo
n=24 Participants
Albumin (Human) 25%, United States Pharmacopeia (USP)
|
|---|---|---|
|
Mean Change in LogRAD Score From Baseline to Endpoint (RADNER Test)
|
0.164 LogRAD
Standard Deviation 0.343
|
0.159 LogRAD
Standard Deviation 0.371
|
SECONDARY outcome
Timeframe: Last measurement at or later than Week 8Population: Intent to Treat subjects with cataract
The LOCS III scale for cortical cataract and posterior subcapsular cataract opacity ranged from 1.0 to 5.0. The LOCS III scale for nuclear opalescence and for nuclear color was 1.0 to 6.0. For all scales, higher values indicate higher opacity, opalescence, or color.
Outcome measures
| Measure |
IGIV-C 10%
n=19 Participants
Immune Globulin Intravenous \[Human\], 10% Caprylate/Chromatography Purified
|
Placebo
n=15 Participants
Albumin (Human) 25%, United States Pharmacopeia (USP)
|
|---|---|---|
|
Proportion of Subjects With an Increase ≥ 2 or More Points in Lens Opacity Classification System (LOCS III) for Nuclear Opalescence, Nuclear Color, Cortical Cataract or Posterior Subcapsular Cataract Categories
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Last measurement at or later than Week 8Population: Intent to Treat
Outcome measures
| Measure |
IGIV-C 10%
n=29 Participants
Immune Globulin Intravenous \[Human\], 10% Caprylate/Chromatography Purified
|
Placebo
n=24 Participants
Albumin (Human) 25%, United States Pharmacopeia (USP)
|
|---|---|---|
|
Presence of Fibrosis and Location Assessed by Slit-lamp
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: At end of treatment (12 weeks)Population: Intent to Treat
Outcome measures
| Measure |
IGIV-C 10%
n=29 Participants
Immune Globulin Intravenous \[Human\], 10% Caprylate/Chromatography Purified
|
Placebo
n=24 Participants
Albumin (Human) 25%, United States Pharmacopeia (USP)
|
|---|---|---|
|
Mean Change From Baseline to Endpoint in Size of Lesion (Largest Dimension Relative to Disk Diameter) Assessed by Central Fluorescein Angiogram Reading Center
|
0.074 Disk Diameter
Standard Deviation 0.209
|
0.173 Disk Diameter
Standard Deviation 0.298
|
Adverse Events
IGIV-C 10%
Placebo
Serious adverse events
| Measure |
IGIV-C 10%
n=30 participants at risk
Immune Globulin Intravenous \[Human\], 10% Caprylate/Chromatography Purified
|
Placebo
n=27 participants at risk
Albumin (Human) 25%, United States Pharmacopeia (USP)
|
|---|---|---|
|
Surgical and medical procedures
Stent placement
|
3.3%
1/30 • Number of events 1
|
0.00%
0/27
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/30
|
3.7%
1/27 • Number of events 1
|
|
Nervous system disorders
Transient ischemic attack
|
0.00%
0/30
|
3.7%
1/27 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/30
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain, upper
|
0.00%
0/30
|
3.7%
1/27 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/30
|
3.7%
1/27 • Number of events 1
|
Other adverse events
| Measure |
IGIV-C 10%
n=30 participants at risk
Immune Globulin Intravenous \[Human\], 10% Caprylate/Chromatography Purified
|
Placebo
n=27 participants at risk
Albumin (Human) 25%, United States Pharmacopeia (USP)
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
6.7%
2/30 • Number of events 2
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain, upper
|
0.00%
0/30
|
7.4%
2/27 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
6.7%
2/30 • Number of events 2
|
11.1%
3/27 • Number of events 3
|
|
General disorders
Fatigue
|
6.7%
2/30 • Number of events 2
|
0.00%
0/27
|
|
Infections and infestations
Cystitis
|
6.7%
2/30 • Number of events 2
|
0.00%
0/27
|
|
Injury, poisoning and procedural complications
Hand fracture
|
6.7%
2/30 • Number of events 2
|
0.00%
0/27
|
|
Investigations
Blood creatine phosphokinase increased
|
6.7%
2/30 • Number of events 2
|
0.00%
0/27
|
|
Investigations
Blood pressure increased
|
6.7%
2/30 • Number of events 2
|
11.1%
3/27 • Number of events 3
|
|
Investigations
Blood urea increased
|
6.7%
2/30 • Number of events 2
|
7.4%
2/27 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
2/30 • Number of events 2
|
0.00%
0/27
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
2/30 • Number of events 2
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
1/30 • Number of events 1
|
7.4%
2/27 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/30
|
7.4%
2/27 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator must send a draft manuscript of the publication or abstract to the sponsor thirty days in advance of submission in order to obtain approval prior to submission of the final version for publication. This will be reviewed promptly and approval will not be withheld unreasonably. In case of a difference of opinion between the sponsor and the investigator(s), the contents of the publication will be discussed in order to find a solution which satisfies both parties.
- Publication restrictions are in place
Restriction type: OTHER