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| Sponsor: | Talecris Biotherapeutics |
|---|---|
| Information provided by: | Talecris Biotherapeutics |
| ClinicalTrials.gov Identifier: | NCT00220805 |
Purpose
This study will evaluate visual improvement in patients treated with Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) or placebo who have Age-Related Macular Degeneration (AMD) with occult Choroidal Neovascularization (CNV).
| Condition | Intervention | Phase |
|---|---|---|
|
Macular Degeneration |
Drug: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified Drug: Albumin (Human) 25%, USP |
Phase II |
| 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 |
| 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 |
| Enrollment: | 57 |
| Study Start Date: | January 2004 |
| Study Completion Date: | May 2005 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Group 1 |
Drug: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
Other Names:
|
| Placebo Comparator: Group 2 |
Drug: Albumin (Human) 25%, USP
Albumin (Human) 20% or 25% will be diluted with 5% glucose to a final concentration of 0.1%.
Other Names:
|
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 (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.
Eligibility| Ages Eligible for Study: | 51 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Germany | |
| Universitatsklinikum Aachen, Augenklinik | |
| Aachen, Germany, 52074 | |
| Augenklinik Tausendfensterhaus | |
| 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 |
More Information
| ClinicalTrials.gov Identifier: | NCT00220805 History of Changes |
| Other Study ID Numbers: | 100586 |
| Study First Received: | September 14, 2005 |
| Last Updated: | July 23, 2009 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Macular Degeneration Choroidal Neovascularization Retinal Degeneration Retinal Diseases Eye Diseases Choroid Diseases Uveal Diseases Neovascularization, Pathologic Metaplasia |
Pathologic Processes Antibodies Immunoglobulins Immunoglobulins, Intravenous Rho(D) Immune Globulin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |