Effectiveness and safety of fluocinolone acetonide intravitreal implant in diabetic macular edema patients considered insufficiently responsive to available therapies (REACT) : a prospective, non-randomized, and multicenter study
© 2023. The Author(s)..
OBJECTIVE: To assess the effectiveness and safety of the intravitreal fluocinolone-acetonide implant (FAc-i) in patients with chronic diabetic macular edema who did not sufficiently respond to other available therapies.
METHODS: This was a multicenter, prospective, non-randomized, and phase-IV observational study conducted on patients with recurrent-DME who were insufficient responders to currently available therapies (REACT-Study). The primary end-point was the mean change in best-corrected-visual-acuity from baseline to month-24 values.
RESULTS: Thirty-one eyes from 31 patients were included in the study. Mean age was 68.0 ± 7.7 years, and 10 (32.3%) were women. Study patients had received 5.3 ± 7.3 previous DME treatments before starting the study. In the overall study sample, BCVA improved from 56.1 ± 12.3 letters at baseline to 62.4 ± 17.0 letters at month-24 (p = 0.0510). The eyes with a baseline BCVA < 70 ETDRS letters had a significant improvement in BCVA from 53.2 ± 10.2 letters at baseline to 61.5 ± 17.9 letters at month-24 (p = 0.0165). In the overall study population, central-subfoveal-thickness (CST) was significantly reduced from 474.0 ± 135.1 µm at baseline to 333.4 ± 135.6 at month-24 (p < 0.0001). Similarly, macular-volume (MV) was significantly reduced from 10.7 ± 2.7 mm3 at baseline to 9.6 ± 2.9 mm3 (p = 0.0027) at month-24. Among the 31 study eyes, 19 (61.3%) required an additional treatment for DME. Throughout the study, 9 (29.0%) eyes required ocular hypotensive medication for controlling their intraocular-pressure and 5 (16.1%) eyes underwent cataract surgery.
CONCLUSIONS: In DME eyes who did not sufficiently respond to previous therapies, the FAc-i was associated with an improvement in visual and anatomic outcomes. There were no unexpected adverse-events.
TRIAL REGISTRATION NUMBER: EudraCT identifier: 2016-001680-37.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:43 |
|---|---|
| Enthalten in: |
International ophthalmology - 43(2023), 12 vom: 26. Dez., Seite 4639-4649 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Ruiz-Moreno, José María [VerfasserIn] |
|---|
| Links: |
|---|
| Anmerkungen: |
Date Completed 16.12.2023 Date Revised 18.12.2023 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1007/s10792-023-02864-2 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM361944802 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM361944802 | ||
| 003 | DE-627 | ||
| 005 | 20231227133653.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1007/s10792-023-02864-2 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1231.xml |
| 035 | |a (DE-627)NLM361944802 | ||
| 035 | |a (NLM)37697082 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Ruiz-Moreno, José María |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Effectiveness and safety of fluocinolone acetonide intravitreal implant in diabetic macular edema patients considered insufficiently responsive to available therapies (REACT) |b a prospective, non-randomized, and multicenter study |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 16.12.2023 | ||
| 500 | |a Date Revised 18.12.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023. The Author(s). | ||
| 520 | |a OBJECTIVE: To assess the effectiveness and safety of the intravitreal fluocinolone-acetonide implant (FAc-i) in patients with chronic diabetic macular edema who did not sufficiently respond to other available therapies | ||
| 520 | |a METHODS: This was a multicenter, prospective, non-randomized, and phase-IV observational study conducted on patients with recurrent-DME who were insufficient responders to currently available therapies (REACT-Study). The primary end-point was the mean change in best-corrected-visual-acuity from baseline to month-24 values | ||
| 520 | |a RESULTS: Thirty-one eyes from 31 patients were included in the study. Mean age was 68.0 ± 7.7 years, and 10 (32.3%) were women. Study patients had received 5.3 ± 7.3 previous DME treatments before starting the study. In the overall study sample, BCVA improved from 56.1 ± 12.3 letters at baseline to 62.4 ± 17.0 letters at month-24 (p = 0.0510). The eyes with a baseline BCVA < 70 ETDRS letters had a significant improvement in BCVA from 53.2 ± 10.2 letters at baseline to 61.5 ± 17.9 letters at month-24 (p = 0.0165). In the overall study population, central-subfoveal-thickness (CST) was significantly reduced from 474.0 ± 135.1 µm at baseline to 333.4 ± 135.6 at month-24 (p < 0.0001). Similarly, macular-volume (MV) was significantly reduced from 10.7 ± 2.7 mm3 at baseline to 9.6 ± 2.9 mm3 (p = 0.0027) at month-24. Among the 31 study eyes, 19 (61.3%) required an additional treatment for DME. Throughout the study, 9 (29.0%) eyes required ocular hypotensive medication for controlling their intraocular-pressure and 5 (16.1%) eyes underwent cataract surgery | ||
| 520 | |a CONCLUSIONS: In DME eyes who did not sufficiently respond to previous therapies, the FAc-i was associated with an improvement in visual and anatomic outcomes. There were no unexpected adverse-events | ||
| 520 | |a TRIAL REGISTRATION NUMBER: EudraCT identifier: 2016-001680-37 | ||
| 650 | 4 | |a Observational Study | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Corticoids | |
| 650 | 4 | |a Diabetic macular edema | |
| 650 | 4 | |a Fluocinolone acetonide intravitreal implant | |
| 650 | 4 | |a VEGF inhibitors | |
| 650 | 7 | |a Glucocorticoids |2 NLM | |
| 650 | 7 | |a Fluocinolone Acetonide |2 NLM | |
| 650 | 7 | |a 0CD5FD6S2M |2 NLM | |
| 650 | 7 | |a Drug Implants |2 NLM | |
| 700 | 1 | |a Adán, Alfredo |e verfasserin |4 aut | |
| 700 | 1 | |a Lafuente, María |e verfasserin |4 aut | |
| 700 | 1 | |a Asencio Durán, Mónica |e verfasserin |4 aut | |
| 700 | 1 | |a Arias Barquet, Luís |e verfasserin |4 aut | |
| 700 | 1 | |a García Layana, Alfredo |e verfasserin |4 aut | |
| 700 | 1 | |a Araiz Iribarren, Javier |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t International ophthalmology |d 1993-1994 |g 43(2023), 12 vom: 26. Dez., Seite 4639-4649 |w (DE-627)NLM000466077 |x 1573-2630 |7 nnns |
| 773 | 1 | 8 | |g volume:43 |g year:2023 |g number:12 |g day:26 |g month:12 |g pages:4639-4649 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1007/s10792-023-02864-2 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 43 |j 2023 |e 12 |b 26 |c 12 |h 4639-4649 | ||