Use of Immune Globulin Intravenous (Human) To Treat Age-Related Macular Degeneration

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Grifols Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00220805
First received: September 14, 2005
Last updated: February 22, 2016
Last verified: February 2016
Results First Received: September 24, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Macular Degeneration
Interventions: Drug: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
Drug: Albumin (Human) 25%, United States Pharmacopeia (USP)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 96 subjects were enrolled (signed the informed consent and screened) in this study at 6 German study centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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subjects, 14 subjects withdrew their consent for participation before randomization and an additional 25 subjects were withdrawn before randomization because of violations of inclusion/exclusion criteria or because their angiograms were rejected by the central reading site as not meeting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.

Reporting Groups
  Description
IGIV-C 10% Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
Placebo Albumin (Human) 25%, United States Pharmacopeia (USP)

Participant Flow:   Overall Study
    IGIV-C 10%     Placebo  
STARTED     30     27  
COMPLETED     22     16  
NOT COMPLETED     8     11  
Adverse Event                 1                 3  
Withdrawal by Subject                 3                 0  
Lack of Efficacy                 1                 0  
Develop. of choroidal neovascularization                 3                 8  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent to treat (ITT) population, which was defined as the primary analysis population, comprised 29 subjects treated with IGIV-C 10% and 24 subjects treated with placebo. A total of 4 subjects were excluded from the ITT population: 1 from IGIV-C 10% and 3 from Placebo.

Reporting Groups
  Description
IGIV-C 10% Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
Placebo Albumin (Human) 25%, United States Pharmacopeia (USP)
Total Total of all reporting groups

Baseline Measures
    IGIV-C 10%     Placebo     Total  
Number of Participants  
[units: participants]
  29     24     53  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     4     4     8  
>=65 years     25     20     45  
Age  
[units: years]
Mean (Standard Deviation)
  74.724  (8.417)     74.042  (10.217)     74.415  (9.189)  
Gender  
[units: participants]
     
Female     20     17     37  
Male     9     7     16  
Region of Enrollment  
[units: participants]
     
Germany     29     24     53  
Visual Acuity Score (VAS) of the Study Eyes  
[units: units on a scale]
Mean (Standard Deviation)
  55.9  (10.4)     58.4  (7.7)     57.0  (9.3)  
Logarithm of the Minimum Angle of Resolution (LogMAR) of the Study Eyes  
[units: LogMAR]
Mean (Standard Deviation)
  0.581  (0.209)     0.533  (0.153)     0.559  (0.186)  



  Outcome Measures
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1.  Primary:   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)   [ Time Frame: 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 ]

2.  Secondary:   Proportion of Subjects Who Improve Visual Acuity From Baseline to Endpoint by ≥ 0.1 LogMAR   [ Time Frame: Last measurement at or later than Week 8 ]

3.  Secondary:   Proportion of Subjects Who Improve Visual Acuity From Baseline to Endpoint by ≥ 0.2 LogMAR   [ Time Frame: Last measurement at or later than Week 8 ]

4.  Secondary:   Mean Change in LogRAD Score From Baseline to Endpoint (RADNER Test)   [ Time Frame: Last measurement at or later than Week 8 ]

5.  Secondary:   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   [ Time Frame: Last measurement at or later than Week 8 ]

6.  Secondary:   Presence of Fibrosis and Location Assessed by Slit-lamp   [ Time Frame: Last measurement at or later than Week 8 ]

7.  Secondary:   Mean Change From Baseline to Endpoint in Size of Lesion (Largest Dimension Relative to Disk Diameter) Assessed by Central Fluorescein Angiogram Reading Center   [ Time Frame: At end of treatment (12 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Henry Li
Organization: Grifols Therapeutics
phone: 1-800-520-2807
e-mail: henry.li@grifols.com



Responsible Party: Grifols Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00220805     History of Changes
Other Study ID Numbers: 100586
Study First Received: September 14, 2005
Results First Received: September 24, 2009
Last Updated: February 22, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices