Dataset Information

Intravitreal Dexamethasone Implant at the Time of Silicon Oil Removal to Treat Persistent Macular Edema after Rhegmatogenous Retinal Detachment Repair.

ABSTRACT:

Background

An intravitreal dexamethasone implant (DEX-I) was found to be effective and safe for the treatment of cystoid macular edema (CME) after vitrectomy for rhegmatogenous retinal detachment (RRD) and in silicone oil (SO)-filled eyes. We aimed to investigate the efficacy and safety of DEX-I at the time of SO removal for the treatment of recalcitrant CME after successful RRD repair.

Methods

A retrospective review of the medical records was performed on 24 consecutive patients (24 eyes) with recalcitrant CME after RRD repair who were treated with a single 0.7-mg DEX-I at the time of SO removal. The main outcome measures were changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT). A regression model was performed to assess the relationship between BCVA and CMT at 6 months and independent variables.

Results

In all 24 patients, CME occurred after RRD repair and remained despite topical therapy. The mean time of CME onset was 27.4 ± 7.7 days after vitrectomy. The mean time between vitrectomy and DEX-I was 106.8 ± 10.1 days. The mean CMT was significantly decreased from 429.6 ± 59.1 µm at baseline to 294 ± 46.4 µm at month 6 (p < 0.0001). The mean BCVA significantly improved from 0.99 ± 0.3 at baseline to 0.60 ± 0.3 at month 6 (p < 0.0001). An elevation of intraocular pressure was observed in one (4.1%) eye, which was medically managed. A univariate regression model revealed a relationship between month-6 BCVA after DEX-I and gender (β = -0.27; p = 0.03) and macular status (β = -0.45; p = 0.001) when RRD occurred. No relationship between month-6 CMT and independent variables was found.

Conclusions

DEX-I at the time of SO removal had an acceptable safety profile and achieved favorable outcomes in eyes affected by recalcitrant CME that occurred after RRD repair. RRD-related macular status is significantly associated with visual acuity after DEX-I.

SUBMITTER: Pignatelli F

PROVIDER: S-EPMC9962319 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

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Intravitreal Dexamethasone Implant at the Time of Silicon Oil Removal to Treat Persistent Macular Edema after Rhegmatogenous Retinal Detachment Repair.

Pignatelli Francesco F Nacucchi Annalisa A Niro Alfredo A Gigliola Samuele S Passidomo Fedele F Donghia Rossella R Addabbo Giuseppe G

Journal of clinical medicine 20230220 4

<h4>Background</h4>An intravitreal dexamethasone implant (DEX-I) was found to be effective and safe for the treatment of cystoid macular edema (CME) after vitrectomy for rhegmatogenous retinal detachment (RRD) and in silicone oil (SO)-filled eyes. We aimed to investigate the efficacy and safety of DEX-I at the time of SO removal for the treatment of recalcitrant CME after successful RRD repair.<h4>Methods</h4>A retrospective review of the medical records was performed on 24 consecutive patients ...[more]

PMID: 36836233

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Project description:Diabetic macular edema (DME) resembles a chronic, low-grade inflammatory reaction, and is characterized by blood-retinal barrier (BRB) breakdown and retinal capillary leakage. Corticosteroids are of therapeutic benefit because of their anti-inflammatory, antiangiogenic, and BRB-stabilizing properties. Delivery modes include periocular and intravitreal (via pars plana) injection. To offset the short intravitreal half-life of corticosteroid solutions (~3 hours) and the need for frequent intravitreal injections, sustained-release intravitreal corticosteroid implants have been developed. Dexamethasone intravitreal implant provides retinal drug delivery for ≤6 months and recently has been approved for use in the treatment of DME. Pooled findings (n=1,048) from two large-scale, randomized Phase III trials indicated that dexamethasone intravitreal implant (0.35 mg and 0.7 mg) administered at ≥6-month intervals produced sustained improvements in best-corrected visual acuity (BCVA) and macular edema. Significantly more patients showed a ≥15-letter gain in BCVA at 3 years with dexamethasone intravitreal implant 0.35 mg and 0.7 mg than with sham injection (18.4% and 22.2% vs 12.0%). Anatomical assessments showed rapid and sustained reductions in macular edema and slowing of retinopathy progression. Phase II study findings suggest that dexamethasone intravitreal implant is effective in focal, cystoid, and diffuse DME, in vitrectomized eyes, and in combination with laser therapy. Ocular complications of dexamethasone intravitreal implant in Phase III trials included cataract-related events (66.0% in phakic patients), intraocular pressure elevation ≥25 mmHg (29.7%), conjunctival hemorrhage (23.5%), vitreous hemorrhage (10.0%), macular fibrosis (8.3%), conjunctival hyperemia (7.2%), eye pain (6.1%), vitreous detachment (5.8%), and dry eye (5.8%); injection-related complications (eg, retinal tear/detachment, vitreous loss, endophthalmitis) were infrequent (<2%). Dexamethasone intravitreal implant offers a viable treatment option for DME, especially in cases that are persistent or treatment (anti-vascular endothelial growth factor/laser) refractory.

Project description:PURPOSE:To evaluate the comparative effectiveness of 3 regional corticosteroid injections for uveitic macular edema (ME): periocular triamcinolone acetonide (PTA), intravitreal triamcinolone acetonide (ITA), and the intravitreal dexamethasone implant (IDI). DESIGN:Multicenter, randomized clinical trial. PARTICIPANTS:Patients with uveitic ME. METHODS:Patients were randomized 1:1:1 to receive 1 of the 3 therapies. Patients with bilateral ME were assigned the same treatment for both eyes. MAIN OUTCOME MEASURES:The primary outcome was the proportion of baseline (PropBL) central subfield thickness (CST) at 8 weeks (CST at 8 weeks/CST at baseline) assessed with OCT by masked readers. Secondary outcomes included ?20% improvement and resolution of ME, best-corrected visual acuity (BCVA), and intraocular pressure (IOP) events over 24 weeks. RESULTS:All treatment groups demonstrated improved CST during follow-up. At 8 weeks, each group had clinically meaningful reductions in CST relative to baseline (PropBL: 0.77, 0.61, and 0.54, respectively, which translates to reductions of 23%, 39%, and 46% for PTA, ITA, and IDI, respectively). Intravitreal triamcinolone acetonide (PropBL ITA/PropBL PTA, hazard ratio [HR], 0.79; 99.87% confidence interval [CI], 0.65-0.96) and IDI (PropBL IDI/PropBL PTA, HR, 0.69; 99.87% CI, 0.56-0.86) had larger reductions in CST than PTA (P < 0.0001). Intravitreal dexamethasone implant was noninferior to ITA at 8 weeks (PropBL IDI/PropBL ITA, HR, 0.88; 99.87% CI, 0.71-1.08). Both ITA and IDI treatments also were superior to PTA treatment in improving and resolving uveitic ME. All treatment groups demonstrated BCVA improvement throughout follow-up. Both ITA and IDI groups had improvements in BCVA that was 5 letters greater than in the PTA group at 8 weeks (P < 0.004). The risk of having IOP ?24 mmHg was higher in the intravitreal treatment groups compared with the periocular group (HR, 1.83; 95% CI, 0.91-3.65 and HR, 2.52; 95% CI, 1.29-4.91 for ITA and IDI, respectively); however, there was no significant difference between the 2 intravitreal treatment groups. CONCLUSIONS:Intravitreal triamcinolone acetonide and the IDI were superior to PTA for treating uveitic ME with modest increases in the risk of IOP elevation. This risk did not differ significantly between intravitreal treatments.

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Project description:PurposeTo evaluate the effectiveness of 3 different intravitreal treatments for persistent or recurrent uveitic macular edema (ME): dexamethasone implant, methotrexate, and ranibizumab.DesignSingle-masked, randomized controlled clinical trial.ParticipantsPatients with minimally active or inactive uveitis and persistent or recurrent uveitic ME in one or both eyes.MethodsPatients at 33 centers were randomized 1:1:1 to receive 1 of the 3 therapies. Patients with bilateral ME received the same treatment in both eyes.Main outcome measuresThe primary outcome, measured at 12 weeks, was reduction in central subfield thickness (CST) expressed as a proportion of baseline (CST per CST at baseline) assessed with spectral-domain OCT by readers masked to treatment assignment. Secondary outcomes included improvement and resolution of ME, change in best-corrected visual acuity (BCVA), and elevations in intraocular pressure (IOP).ResultsOne hundred ninety-four participants (225 eligible eyes) were randomized to dexamethasone (n = 65 participants and 77 eyes), methotrexate (n = 65 participants and 79 eyes), or ranibizumab (n = 64 participants and 69 eyes). All received at least 1 injection of the assigned treatment. At the 12-week primary outcome point, each group showed significant reductions in CST relative to baseline: 35%, 11%, and 22% for dexamethasone, methotrexate, and ranibizumab, respectively. Reduction of ME was significantly greater in the dexamethasone group than for either methotrexate (P < 0.01) or ranibizumab (P = 0.018). Only the dexamethasone group showed a statistically significant improvement in BCVA during follow-up (4.86 letters; P < 0.001). Elevations of IOP by 10 mmHg, to 24 mmHg or more, or both were more common in the dexamethasone group; IOP spikes to 30 mmHg or more were uncommon overall and were not significantly different among groups. Reductions in BCVA of 15 letters or more were more common in the methotrexate group and typically were attributable to persistent ME.ConclusionsAt 12 weeks, in eyes with minimally active or inactive uveitis, dexamethasone was significantly better at treating persistent or recurrent ME than methotrexate or ranibizumab. Risk of IOP elevation was greater with dexamethasone, but elevations to levels of 30 mmHg or more were infrequent.Financial disclosure(s)Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Project description:BackgroundThe purpose of this study was to evaluate the real-world use, efficacy, and safety of one or more dexamethasone intravitreal implant(s) 0.7 mg (DEX implant) in patients with macular edema (ME).MethodsThis was a retrospective cohort study of patients with ME secondary to retinal disease treated at ten Canadian retina practices, including one uveitis center. Best-corrected visual acuity (BCVA), central retinal thickness (CRT), intraocular pressure (IOP), glaucoma and cataract surgery, and safety data were collected from the medical charts of patients with ≥3 months of follow-up after the initial DEX implant.ResultsOne hundred and one patient charts yielded data on 120 study eyes, including diagnoses of diabetic ME (DME) (n=34), retinal vein occlusion (RVO, n=30; branch in 19 and central in 11), and uveitis (n=23). Patients had a mean age of 60.9 years, and 73.3% of the study eyes had ME for a duration of ≥12 months prior to DEX implant injection(s). Baseline mean (± standard error) BCVA was 0.63±0.03 logMAR (20/86 Snellen equivalents) and mean CRT was 474.4±18.2 μm. The mean number of DEX implant injections was 1.7±0.1 in all study eyes; 44.2% of eyes had repeat DEX implant injections (reinjection interval 2.3-4.9 months). The greatest mean peak changes in BCVA lines of vision occurred in study eyes with uveitis (3.3±0.6, P<0.0001), followed by RVO (1.3±0.5, P<0.01) and DME (0.7±0.5, P>0.05). Significant decreases in CRT were observed: -255.6±43.6 μm for uveitis, -190.9±23.5 μm for DME, and -160.7±39.6 μm for RVO (P<0.0001 for all cohorts). IOP increases of ≥10 mmHg occurred in 20.6%, 24.1%, and 22.7% of DME, RVO, and uveitis study eyes, respectively. IOP-lowering medication was initiated in 29.4%, 16.7%, and 8.7% of DME, RVO, and uveitis study eyes, respectively. Glaucoma surgery was performed in 1.7% of all study eyes and cataract surgery in 29.8% of all phakic study eyes receiving DEX implant(s).ConclusionDEX implant(s) alone or combined with other treatments and/or procedures resulted in functional and anatomic improvements in long-standing ME associated with retinal disease.

Dataset Information

Intravitreal Dexamethasone Implant at the Time of Silicon Oil Removal to Treat Persistent Macular Edema after Rhegmatogenous Retinal Detachment Repair.

Background

Methods

Results

Conclusions

Publications

Intravitreal Dexamethasone Implant at the Time of Silicon Oil Removal to Treat Persistent Macular Edema after Rhegmatogenous Retinal Detachment Repair.

Similar Datasets

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