At a glance
ClinicalIndex Comparison Record- ✓Best corrected visual acuity between 20/40 and 20/200 (ETDRS)
- ✓Patient-reported visual loss within 3 months prior to study entry
- ✓Documented visual loss on visual acuity chart in 3-month period prior to run-in
- ✕Prior IGIV treatment within 3 months
- ✕Prior photodynamic therapy, vitrectomy, or transpupillary thermotherapy for CNV
- ✕Subfoveal blood ≥1/2 disc diameter during run-in period
- ✕History of anaphylaxis or severe systemic response to immunoglobulin or blood products
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified and Albumin (Human) 25%, United States Pharmacopeia (USP) for Macular Degeneration. Completed, enrolled 96 participants across 7 sites.
Detailed 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).
Study Details
Timeline
Interventions
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.
Albumin (Human) 20% or 25% will be diluted with 5% glucose to a final concentration of 0.1%.