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A single-arm, investigator-initiated study of the efficacy, safety, and tolerability of intravitreal aflibercept injection in subjects with exudative age-related macular degeneration previously treated with ranibizumab or bevacizumab (ASSESS study): 12-month analysis.

Singh RP, Srivastava SK, Ehlers JP, Silva FQ, Bedi R, Schachat AP, Kaiser PK - Clin Ophthalmol (2015)

Bottom Line: There was a mean decrease in CST of -50.3 μm (P<0.001) and a mean increase in ETDRS BCVA of +9.2 letters (P<0.001).Fifty percent of subjects were 20/40 or better, and 11.5% of subjects were 20/200 or worse at month 12.Fixed IAI dosing regimen for 12 months demonstrated improved anatomic and vision endpoints in subjects with active exudative AMD.

View Article: PubMed Central - PubMed

Affiliation: Cole Eye Institute, Cleveland Clinic, Cleveland, OH, USA.

ABSTRACT

Summary statement: In subjects with active exudative age-related macular degeneration, treating with a fixed intravitreal aflibercept injection dosing regimen for 12 months demonstrated improved anatomic and vision endpoints from baseline.

Purpose: Switching therapies in neovascular age-related macular degeneration (AMD) may offer an advantage for some patients. This study evaluates the efficacy of intravitreal aflibercept injection (IAI) in subjects previously treated with ranibizumab and/or bevacizumab.

Methods: Subjects (n=26) were given monthly 2 mg of IAI for 3 months, followed by 2 mg once in every 2 months for up to 12 months. The mean absolute change from baseline in central subfield thickness (CST) measured by optical coherence tomography and the mean change from baseline in best-corrected visual acuity (BCVA) early treatment in diabetic retinopathy study (ETDRS) letter score were obtained. Additionally, the percentage of subjects who gained or lost ≥15 letters of vision and the percentage of subjects who are 20/40 or better or 20/200 or worse were evaluated.

Results: There was a mean decrease in CST of -50.3 μm (P<0.001) and a mean increase in ETDRS BCVA of +9.2 letters (P<0.001). Twenty-seven percent of subjects experienced a ≥15-letter improvement in visual acuity, and no subject lost ≥3 lines of vision from baseline. Fifty percent of subjects were 20/40 or better, and 11.5% of subjects were 20/200 or worse at month 12.

Conclusion: Fixed IAI dosing regimen for 12 months demonstrated improved anatomic and vision endpoints in subjects with active exudative AMD.

No MeSH data available.


Related in: MedlinePlus

ASSESS study design.Abbreviations: ETDRS, early treatment in diabetic retinopathy study; IAI, intravitreal aflibercept injection.
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f1-opth-9-1759: ASSESS study design.Abbreviations: ETDRS, early treatment in diabetic retinopathy study; IAI, intravitreal aflibercept injection.

Mentions: Subjects were given 2 mg (0.05 mL) of IAI administered every month for the first 3 months, followed by 2 mg (0.05 mL) once every 2 months as per the drug label (Figure 1) for the next 9 months. Although imaging and clinical values were recorded at follow-up visits, treatment decisions were not based on these values, but on a fixed dosing regimen. Regeneron Pharmaceuticals, Inc. supplied the intravitreal aflibercept. The drug was administered using the standard aseptic intravitreal techniques as detailed in the package insert.14


A single-arm, investigator-initiated study of the efficacy, safety, and tolerability of intravitreal aflibercept injection in subjects with exudative age-related macular degeneration previously treated with ranibizumab or bevacizumab (ASSESS study): 12-month analysis.

Singh RP, Srivastava SK, Ehlers JP, Silva FQ, Bedi R, Schachat AP, Kaiser PK - Clin Ophthalmol (2015)

ASSESS study design.Abbreviations: ETDRS, early treatment in diabetic retinopathy study; IAI, intravitreal aflibercept injection.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4590671&req=5

f1-opth-9-1759: ASSESS study design.Abbreviations: ETDRS, early treatment in diabetic retinopathy study; IAI, intravitreal aflibercept injection.
Mentions: Subjects were given 2 mg (0.05 mL) of IAI administered every month for the first 3 months, followed by 2 mg (0.05 mL) once every 2 months as per the drug label (Figure 1) for the next 9 months. Although imaging and clinical values were recorded at follow-up visits, treatment decisions were not based on these values, but on a fixed dosing regimen. Regeneron Pharmaceuticals, Inc. supplied the intravitreal aflibercept. The drug was administered using the standard aseptic intravitreal techniques as detailed in the package insert.14

Bottom Line: There was a mean decrease in CST of -50.3 μm (P<0.001) and a mean increase in ETDRS BCVA of +9.2 letters (P<0.001).Fifty percent of subjects were 20/40 or better, and 11.5% of subjects were 20/200 or worse at month 12.Fixed IAI dosing regimen for 12 months demonstrated improved anatomic and vision endpoints in subjects with active exudative AMD.

View Article: PubMed Central - PubMed

Affiliation: Cole Eye Institute, Cleveland Clinic, Cleveland, OH, USA.

ABSTRACT

Summary statement: In subjects with active exudative age-related macular degeneration, treating with a fixed intravitreal aflibercept injection dosing regimen for 12 months demonstrated improved anatomic and vision endpoints from baseline.

Purpose: Switching therapies in neovascular age-related macular degeneration (AMD) may offer an advantage for some patients. This study evaluates the efficacy of intravitreal aflibercept injection (IAI) in subjects previously treated with ranibizumab and/or bevacizumab.

Methods: Subjects (n=26) were given monthly 2 mg of IAI for 3 months, followed by 2 mg once in every 2 months for up to 12 months. The mean absolute change from baseline in central subfield thickness (CST) measured by optical coherence tomography and the mean change from baseline in best-corrected visual acuity (BCVA) early treatment in diabetic retinopathy study (ETDRS) letter score were obtained. Additionally, the percentage of subjects who gained or lost ≥15 letters of vision and the percentage of subjects who are 20/40 or better or 20/200 or worse were evaluated.

Results: There was a mean decrease in CST of -50.3 μm (P<0.001) and a mean increase in ETDRS BCVA of +9.2 letters (P<0.001). Twenty-seven percent of subjects experienced a ≥15-letter improvement in visual acuity, and no subject lost ≥3 lines of vision from baseline. Fifty percent of subjects were 20/40 or better, and 11.5% of subjects were 20/200 or worse at month 12.

Conclusion: Fixed IAI dosing regimen for 12 months demonstrated improved anatomic and vision endpoints in subjects with active exudative AMD.

No MeSH data available.


Related in: MedlinePlus