Use of Immune Globulin Intravenous (Human) To Treat Age-Related Macular Degeneration
|Macular Degeneration||Drug: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified Drug: Albumin (Human) 25%, United States Pharmacopeia (USP)||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of IGIV-C, 10% Treatment in Subjects With Pure Occult Choroidal Neovascularization Due to Age Related Macular Degeneration|
- 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 ]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.
- 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 ]
- 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 ]
- Mean Change in LogRAD Score From Baseline to Endpoint (RADNER Test) [ Time Frame: Last measurement at or later than Week 8 ]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.
- 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 ]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.
- Presence of Fibrosis and Location Assessed by Slit-lamp [ Time Frame: Last measurement at or later than Week 8 ]
- 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) ]
|Study Start Date:||January 2004|
|Study Completion Date:||May 2005|
|Primary Completion Date:||May 2005 (Final data collection date for primary outcome measure)|
|Experimental: Group 1||
Drug: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
The dose per infusion cycle was 2 g/kg body weight over 5 consecutive days (= 4 mL/kg body weight/infusion). The infusion duration was approximately 1.5 - 2 h.
|Placebo Comparator: Group 2||
Drug: Albumin (Human) 25%, United States Pharmacopeia (USP)
Albumin (Human) 20% or 25% will be diluted with 5% glucose to a final concentration of 0.1%.
The purpose of this trial is to investigate the effect of IGIV-C in subjects suffering from AMD with occult CNV where fewer treatment options exist for patients with this disease form.
This study is designed as a randomized, double-blind, parallel group, placebo-controlled prospective trial. Sixty patients, 30 per treatment group, with newly diagnosed pure occult CNV defined by angiography diagnostic criteria will be enrolled. If a subject has more than one eye affected with occult CNV, the eye with the better vision as measured by visual acuity ( Logarithm of the Minimum Angle of Resolution [LogMAR] score) will be entered as the study eye.
Patients will be randomized to receive either IGIV-C at a dose of 2 g/kg body weight (bw) over 5 consecutive days or matching placebo. Additional 2 study drug treatment courses (IGIV-C or matching placebo) will be administered every 4 weeks at the same dose of 2 g/kg bw given over 5 days. Subjects' visual acuity will be measured and reported as LogMAR at screening, week 0 (baseline), day 5, week 4, week 8 and week 12. If at anytime during the study the subject's visual acuity worsens by ≥ 2 lines (0.2 on the LogMAR score), then a slit lamp examination will be performed and an angiogram will be conducted; the patient would be discontinued if the worsening is due to some other reason outside of the occult CNV or if the disease has changed from pure occult to the classic or mixed form.
Subjects will be evaluated for efficacy (LogMAR score) at endpoint (at week 12 or at last LogMAR assessment at or after week 8, if the subject prematurely discontinues the trial).
At the end of the treatment period (week 12), patients will be entered into a 3 month observation period with monthly visual acuity LogMAR score assessments.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00220805
|Universitatsklinikum Aachen, Augenklinik|
|Aachen, Germany, 52074|
|Duisburg, Germany, 47119|
|St. Martinus-Krankenhaus, Augenabteilung|
|Düsseldorf, Germany, 40219|
|Medizinische Eirnrichtungen der Universitat Essen, Klinik fur Erkrankungen des hinteren Augenabschnittes|
|Essen, Germany, 45147|
|Kliniken und Polikliniken der Albert Ludwigs Universität|
|Freiburg, Germany, 79106|
|Medizinische Einrichtungen der Universitat zu Koln, Centrum fur Augenheilkunde|
|Koln, Germany, 50931|
|Klininkum der Eberhard-Karls-Universitat Tubingen, Universitats-Augenklinik|
|Tubingen, Germany, 72076|
|Principal Investigator:||Richard Brunner, MD||Center of Ophthalmology, University of Cologne, Germany|