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Dexamethasone implants in paediatric patients with noninfectious intermediate or posterior uveitis: first prospective
Sibylle Winterhalter1, Uwe Diedrich Behrens2, Daniel Salchow3
1Department of Ophthalmology, Campus Virchow- Klinikum, Charité - University Medicine Berlin, corporate member of Freie Universität Berlin, Humboldt- Universität zu Berlin and Berlin Institute of Health, Berlin, Germany. sibylle.winterhalter@charite.de.
Insights
Dexamethasone implants effectively improved vision and reduced inflammation in pediatric uveitis patients. While intraocular pressure increased, it was manageable without surgery, indicating a favorable safety profile.
Area of Science:
- Ophthalmology
- Pediatric Medicine
- Pharmacology
Background:
- Noninfectious intermediate or posterior uveitis affects pediatric patients.
- Dexamethasone (DEX) implants offer a potential treatment option.
Purpose of the Study:
- To evaluate the efficacy and safety of dexamethasone (DEX) implants.
- To assess outcomes in pediatric patients with noninfectious intermediate or posterior uveitis.
Main Methods:
- Prospective, single-center, exploratory case series.
- Enrolled children and adolescents (6-17 years) with vitreous haze (≥1.5+) or cystoid macular edema (CME >300 μm).
- Primary endpoint: Vitreous haze score at 2 months; Secondary endpoints: Best corrected visual acuity (BCVA), central retinal thickness (CRT), and concomitant medication at 6 months; Safety endpoints: Intraocular pressure (IOP) and cataract formation.
Main Results:
- Three patients completed the study.
- Significant improvements observed in vitreous haze, BCVA, and CRT.
- All patients experienced increased IOP, managed medically without requiring glaucoma surgery.
- No cataract progression occurred.
Conclusions:
- DEX implants demonstrated efficacy in improving visual acuity and reducing inflammation in pediatric uveitis.
- Increased IOP is a potential side effect in pediatric patients and requires monitoring and management.
Background:
To evaluate the efficacy and safety of dexamethasone (DEX) implants in paediatric patients with noninfectious intermediate or posterior uveitis.
Methods:
Prospective single center exploratory case series. Children and adolescents, 6 to 17 years old, with a vitreous haze score of ≥1.5+ or cystoid macular edema (CME) of >300 μm were enrolled. Vitreous haze score at month 2 was chosen as primary endpoint. Best corrected visual acuity (BCVA), central retinal thickness (CRT) and concomitant medication at month 6 were defined as secondary endpoints. Intraocular pressure (IOP) and cataract formation were determined as safety endpoints.
Results:
Three out of 6 eligible patients participated in the case series. At month 2, vitreous haze was reduced from a score of 1.5+ to 0.5+ and 0 and BCVA improved by ≥3 lines, ≥4 lines and ≥2 lines of Early Treatment of Diabetic Retinopathy (ETDRS)-letters, respectively. Visual acuity gain was accompanied by a CRT reduction of -186 μm and -83 μm in the first and third patient, in whom CME was the indication for DEX implantation. A reduction of concomitant medication was achieved in 1 patient. IOP increase was seen in all 3 patients, but could be treated sufficiently with primarily IOP lowering medications and without need for glaucoma surgery. Cataract progression did not occur.
Conclusions:
DEX implants led to an improvement in all endpoints, especially BCVA. This study confirms that IOP rises may also occur in the paediatric population and should be monitored and treated appropriately.
Trial Registration:
European Union Drug Regulating Authorities Clinical Trials (EudraCT)- nr: 2013-000541-39.
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