Tags

Type your tag names separated by a space and hit enter

Dexamethasone intravitreal implant in retinal vein occlusion: real-life data from a prospective, multicenter clinical trial.
Graefes Arch Clin Exp Ophthalmol. 2017 Jan; 255(1):77-87.GA

Abstract

PURPOSE

To evaluate the relationship between duration of macular edema associated with retinal vein occlusion (RVO) and the achievement of vision gain in patients receiving dexamethasone intravitreal implant (DEX implant) in real-world clinical practice, and to define patterns of use of DEX implant and its efficacy and safety in the treatment of patients with RVO in clinical practice.

METHODS

This prospective, open-label, multicenter, 6-month observational phase IV study conducted at 70 sites in Germany enrolled patients diagnosed with macular edema following branch or central RVO (BRVO, CRVO) who were given DEX implant. Follow-up visits and evaluations occurred in accordance with normal clinical practice. Re-treatment with DEX implant and use of other RVO therapies was at the discretion of the treating physician. The primary endpoint was mean change in best-corrected visual acuity (BCVA) from baseline at week 12.

RESULTS

The analysis population consisted of 573 patients (64 % BRVO, 36 % CRVO). Patients received a mean of 1.17 DEX implant treatments during the study period; 84.3 % of patients received a single DEX implant and 19.9 % received adjunctive other RVO treatment. Among patients with analyzable BCVA data at baseline and week 12 (n = 351), mean change from baseline BCVA at week 12 was -0.16 (standard deviation, 0.30) logMAR (+7.8 approximate Early Treatment Diabetic Retinopathy Study [ETDRS] letters) (p < 0.001), and 33.9 % of patients had gained at least 3 lines in BCVA from baseline. Mean change from baseline BCVA at week 12 was +9.5, +7.3, and +5.4 approximate ETDRS letters in patients with macular edema duration < 90 days, from 90 to 180 days, and >180 days respectively. Improvement in BCVA through week 24 and decreases in central retinal thickness were seen in both BRVO and CRVO. The most common adverse drug reaction was increased intraocular pressure. No glaucoma incisional surgeries were required.

CONCLUSIONS

DEX implant was effective in improving BCVA and central retinal thickness in patients with BRVO and CRVO in real-world clinical practice. The largest gains in BCVA over 6 months occurred in patients with recent onset macular edema, confirming the benefit of early treatment. DEX implant was well tolerated and had an acceptable safety profile.

Authors+Show Affiliations

Department of Ophthalmology, University of Münster Medical School, Domagkstr 15, D-48149, Münster, Germany. eter@uni-muenster.de.Eye Hospital St. Joseph-Stift, Bremen, Germany.Augenabteilung, Sankt Gertrauden Krankenhaus, Berlin, Germany.University Eye Care Hospital, Göttingen, Germany.Allergan plc, Marlow, UK.Allergan plc, Marlow, UK.No affiliation info available

Pub Type(s)

Clinical Trial, Phase IV
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

27460280

Citation

Eter, Nicole, et al. "Dexamethasone Intravitreal Implant in Retinal Vein Occlusion: Real-life Data From a Prospective, Multicenter Clinical Trial." Graefe's Archive for Clinical and Experimental Ophthalmology = Albrecht Von Graefes Archiv Fur Klinische Und Experimentelle Ophthalmologie, vol. 255, no. 1, 2017, pp. 77-87.
Eter N, Mohr A, Wachtlin J, et al. Dexamethasone intravitreal implant in retinal vein occlusion: real-life data from a prospective, multicenter clinical trial. Graefes Arch Clin Exp Ophthalmol. 2017;255(1):77-87.
Eter, N., Mohr, A., Wachtlin, J., Feltgen, N., Shirlaw, A., & Leaback, R. (2017). Dexamethasone intravitreal implant in retinal vein occlusion: real-life data from a prospective, multicenter clinical trial. Graefe's Archive for Clinical and Experimental Ophthalmology = Albrecht Von Graefes Archiv Fur Klinische Und Experimentelle Ophthalmologie, 255(1), 77-87. https://doi.org/10.1007/s00417-016-3431-x
Eter N, et al. Dexamethasone Intravitreal Implant in Retinal Vein Occlusion: Real-life Data From a Prospective, Multicenter Clinical Trial. Graefes Arch Clin Exp Ophthalmol. 2017;255(1):77-87. PubMed PMID: 27460280.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Dexamethasone intravitreal implant in retinal vein occlusion: real-life data from a prospective, multicenter clinical trial. AU - Eter,Nicole, AU - Mohr,Andreas, AU - Wachtlin,Joachim, AU - Feltgen,Nicolas, AU - Shirlaw,Andrew, AU - Leaback,Richard, AU - ,, Y1 - 2016/07/26/ PY - 2016/03/07/received PY - 2016/06/22/accepted PY - 2016/05/22/revised PY - 2016/7/28/pubmed PY - 2017/8/10/medline PY - 2016/7/28/entrez KW - Branch retinal vein occlusion KW - Central retinal thickness KW - Central retinal vein occlusion KW - Dexamethasone KW - Intravitreal KW - Macular edema SP - 77 EP - 87 JF - Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie JO - Graefes Arch Clin Exp Ophthalmol VL - 255 IS - 1 N2 - PURPOSE: To evaluate the relationship between duration of macular edema associated with retinal vein occlusion (RVO) and the achievement of vision gain in patients receiving dexamethasone intravitreal implant (DEX implant) in real-world clinical practice, and to define patterns of use of DEX implant and its efficacy and safety in the treatment of patients with RVO in clinical practice. METHODS: This prospective, open-label, multicenter, 6-month observational phase IV study conducted at 70 sites in Germany enrolled patients diagnosed with macular edema following branch or central RVO (BRVO, CRVO) who were given DEX implant. Follow-up visits and evaluations occurred in accordance with normal clinical practice. Re-treatment with DEX implant and use of other RVO therapies was at the discretion of the treating physician. The primary endpoint was mean change in best-corrected visual acuity (BCVA) from baseline at week 12. RESULTS: The analysis population consisted of 573 patients (64 % BRVO, 36 % CRVO). Patients received a mean of 1.17 DEX implant treatments during the study period; 84.3 % of patients received a single DEX implant and 19.9 % received adjunctive other RVO treatment. Among patients with analyzable BCVA data at baseline and week 12 (n = 351), mean change from baseline BCVA at week 12 was -0.16 (standard deviation, 0.30) logMAR (+7.8 approximate Early Treatment Diabetic Retinopathy Study [ETDRS] letters) (p < 0.001), and 33.9 % of patients had gained at least 3 lines in BCVA from baseline. Mean change from baseline BCVA at week 12 was +9.5, +7.3, and +5.4 approximate ETDRS letters in patients with macular edema duration < 90 days, from 90 to 180 days, and >180 days respectively. Improvement in BCVA through week 24 and decreases in central retinal thickness were seen in both BRVO and CRVO. The most common adverse drug reaction was increased intraocular pressure. No glaucoma incisional surgeries were required. CONCLUSIONS: DEX implant was effective in improving BCVA and central retinal thickness in patients with BRVO and CRVO in real-world clinical practice. The largest gains in BCVA over 6 months occurred in patients with recent onset macular edema, confirming the benefit of early treatment. DEX implant was well tolerated and had an acceptable safety profile. SN - 1435-702X UR - https://www.unboundmedicine.com/medline/citation/27460280/Dexamethasone_intravitreal_implant_in_retinal_vein_occlusion:_real_life_data_from_a_prospective_multicenter_clinical_trial_ L2 - https://dx.doi.org/10.1007/s00417-016-3431-x DB - PRIME DP - Unbound Medicine ER -