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

NCT00220805 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2016-03-21

Study results available
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Summary

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).

Conditions

  • Macular Degeneration

Interventions

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.

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%.

Sponsors & Collaborators

  • Grifols Therapeutics LLC

    lead INDUSTRY

Principal Investigators

  • Richard Brunner, MD · Center of Ophthalmology, University of Cologne, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
51 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2005-05-31
Completion
2005-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00220805 on ClinicalTrials.gov