Abstract | AIM: METHODS: Patients (n=26) were enrolled in a 12-month prospective, interventional, single arm, investigator-initiated study with planned 6-month interim analysis. Patients with active exudative AMD, previously treated with ranibizumab and/or bevacizumab, were treated with 2 mg IAI every month for the first 3 months, followed by a fixed dosing schedule of 2 mg IAI every 2 months. The primary study endpoint was the mean absolute change from baseline central subfield thickness (CST) at month 12 as measured by SDOCT. Secondary outcomes included mean change from baseline best-corrected visual acuity (BCVA) score, percentage of subjects who gained or lost greater than or equal to 15 letters of vision, percentage of subjects who are 20/40 or better, percentage of subjects who are 20/200 or worse, and the incidence of adverse events (AE) and serious AEs. RESULTS: Planned 6-month interim analysis demonstrated a mean decrease in CST of 38.6 µm (p<0.001) and a mean increase in ETDRS BCVA of +5.9 letters (p<0.001). Fifteen percent of subjects experienced a greater than 15-letter improvement in visual acuity, 84.6% of patients gained visual acuity, and no patient lost 3 lines of vision from baseline. Forty-two percent of subjects were 20/40 or better, and 11.5% of subjects were 20/200 or worse at month 6. No serious ocular or systemic AEs were encountered. CONCLUSIONS: IAI-treated eyes demonstrated improved short-term functional and anatomic endpoints in subjects with active exudative AMD switching from previous anti- VEGF treatment when given in a fixed dosing scheme for 6 months. TRIAL REGISTRATION NUMBER: NCT01617148.
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Authors | Rishi P Singh, Sunil Srivastava, Justis P Ehlers, Rumneek Bedi, Andrew P Schachat, Peter K Kaiser |
Journal | The British journal of ophthalmology
(Br J Ophthalmol)
Vol. 98 Suppl 1
Pg. i22-27
(Jun 2014)
ISSN: 1468-2079 [Electronic] England |
PMID | 24836866
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions. |
Chemical References |
- Angiogenesis Inhibitors
- Antibodies, Monoclonal, Humanized
- Recombinant Fusion Proteins
- aflibercept
- Bevacizumab
- Receptors, Vascular Endothelial Growth Factor
- Ranibizumab
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Topics |
- Aged
- Aged, 80 and over
- Angiogenesis Inhibitors
(administration & dosage)
- Antibodies, Monoclonal, Humanized
(administration & dosage)
- Bevacizumab
- Drug Therapy, Combination
- Female
- Fluorescein Angiography
- Follow-Up Studies
- Fundus Oculi
- Humans
- Intravitreal Injections
- Male
- Prospective Studies
- Ranibizumab
- Receptors, Vascular Endothelial Growth Factor
(administration & dosage)
- Recombinant Fusion Proteins
(administration & dosage)
- Single-Blind Method
- Time Factors
- Tomography, Optical Coherence
- Treatment Outcome
- Visual Acuity
- Wet Macular Degeneration
(drug therapy, pathology)
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