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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

OCT fluid status in patients at month 12.Abbreviation: OCT, optical coherence tomography.
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f5-opth-9-1759: OCT fluid status in patients at month 12.Abbreviation: OCT, optical coherence tomography.

Mentions: A total of 45.5% patients manifested intraretinal fluid, and 63.6% presented with subretinal fluid at baseline. At 12 months, 22.7% of study eyes exhibited intraretinal fluid, and 50% of study eyes exhibited subretinal fluid. At month 12, 30.8% of study eyes exhibited an anatomical improvement in subretinal fluid, 46.2% demonstrated anatomically stable subretinal fluid in comparison to their baseline visit, and 23.1% had worsened subretinal fluid (Figure 5). In comparison to baseline, 34.6% of subjects had anatomically improved intraretinal fluid, 53.9% were anatomically stable, and 11.5% had worsened intraretinal fluid. Improvement in PED was seen in 15.4% of study eyes, 69.2% were anatomically stable, and 15.4% of PEDs were anatomically worse compared to baseline. Figure 6 is a case representation of a patient within the trial.


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)

OCT fluid status in patients at month 12.Abbreviation: OCT, optical coherence tomography.
© Copyright Policy
Related In: Results  -  Collection

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

f5-opth-9-1759: OCT fluid status in patients at month 12.Abbreviation: OCT, optical coherence tomography.
Mentions: A total of 45.5% patients manifested intraretinal fluid, and 63.6% presented with subretinal fluid at baseline. At 12 months, 22.7% of study eyes exhibited intraretinal fluid, and 50% of study eyes exhibited subretinal fluid. At month 12, 30.8% of study eyes exhibited an anatomical improvement in subretinal fluid, 46.2% demonstrated anatomically stable subretinal fluid in comparison to their baseline visit, and 23.1% had worsened subretinal fluid (Figure 5). In comparison to baseline, 34.6% of subjects had anatomically improved intraretinal fluid, 53.9% were anatomically stable, and 11.5% had worsened intraretinal fluid. Improvement in PED was seen in 15.4% of study eyes, 69.2% were anatomically stable, and 15.4% of PEDs were anatomically worse compared to baseline. Figure 6 is a case representation of a patient within the trial.

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