Ophthalmology. Retina最新文献

Objective: To demonstrate the therapeutic similarity of CT-P42 compared with reference aflibercept (Eylea) in adult patients with diabetic macular edema (DME).

Design: Randomized, active-controlled, double-masked, phase III clinical trial PARTICIPANTS: Patients with a diagnosis of either type 1 or 2 diabetes mellitus with DME involving the center of the macula.

Methods: Patients were randomized (1:1) to receive either CT-P42 or reference aflibercept (2 mg/0.05 ml) by intravitreal injection every 4 weeks (5 doses), then every 8 weeks (4 doses), in the main study period. Results up to week 24 are reported herein.

Main outcome measures: The primary end point was mean change from baseline at week 8 in best-corrected visual acuity (BCVA) using the ETDRS chart. Equivalence between CT-P42 and reference aflibercept was to be concluded if the 2-sided 95% confidence interval (CI) (global assumptions) and 2-sided 90% CI (United States Food and Drug Administration [FDA] assumptions) for the treatment difference fell entirely within the equivalence margin of ±3 letters, as assessed in the full analysis set.

Results: Overall, 348 patients were randomized (CT-P42: 173; reference aflibercept: 175). Best-corrected visual acuity improved from baseline to week 8 in both groups, with a least squares mean (standard error) improvement of 9.43 (0.798) and 8.85 (0.775) letters in the CT-P42 and reference aflibercept groups, respectively. The estimated between-group treatment difference was 0.58 letters, with the CIs within the predefined equivalence margin of ±3 letters (95% CI, -0.73 to 1.88 [global]; 90% CI, -0.52 to 1.67 [FDA]). Through week 24, other efficacy results for the 2 groups, in terms of change in BCVA and retinal central subfield thickness, as well as ETDRS Diabetic Retinopathy Severity Scale score, supported therapeutic similarity. Pharmacokinetics, usability, safety (including the proportions of patients experiencing ≥1 treatment-emergent adverse event [CT-P42: 50.3%; reference aflibercept: 53.7%]), and immunogenicity were also comparable between groups.

Conclusions: This study in patients with DME demonstrated equivalence between CT-P42 and reference aflibercept (2 mg/0.05 ml) in terms of efficacy, with similar pharmacokinetic, usability, safety, and immunogenicity profiles.

Financial disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Purpose: To determine the proportion and characteristics of eyes with neovascular age-related macular degeneration (nAMD) treated with the Port Delivery System (PDS) with ranibizumab that receive supplemental intravitreal ranibizumab injections because of changes in best-corrected visual acuity (BCVA) or central subfield thickness (CST), or both, and to investigate the safety and efficacy of supplemental injections in eyes with the PDS.

Design: Post hoc analyses of data from the phase III, randomized, multicenter, open-label, active-comparator Archway trial (NCT03677934).

Participants: Adults with nAMD diagnosed within 9 months of screening previously responsive to anti-VEGF therapy.

Intervention: Four hundred eighteen patients were randomized to the PDS with ranibizumab 100 mg/ml with fixed refill-exchanges every 24 weeks (Q24W) or monthly intravitreal ranibizumab 0.5 mg for 96 weeks.

Results: Of the 246 eyes treated with the PDS Q24W and assessed for supplemental treatment criteria, the vast majority (94.6%-98.4%) did not receive supplemental treatment during each retreatment interval, with 87.4% not receiving supplemental treatment at any point during the trial. Of the 31 eyes receiving supplemental treatment, 58.1% received 1 injection and 32.3% received 2. At baseline, eyes receiving supplemental treatment were significantly more likely to have thicker retinas (mean CST, 370.5μm vs. 304.4μm; P = 0.0001), subretinal fluid (54.8% vs. 21.2%; P < 0.0001), and larger pigment epithelial detachment height (215.7 μm vs. 175.9 μm; P = 0.003). These features have previously been associated with difficult-to-treat nAMD. Although BCVA and CST generally remained constant throughout the trial in eyes without supplemental treatment, the small number of eyes receiving supplemental treatment on average lost 1 line of vision from baseline to week 96 (mean, -5.7 ETDRS score letters) and CST continued to increase over time. Absolute BCVA at week 96 was similar irrespective of supplemental treatment status (71.1 and 73.7 letters). Best-corrected visual acuity and CST generally improved within 28 days of supplemental treatment.

Conclusions: Although the PDS Q24W effectively maintains vision and retinal stability in most eyes with nAMD, a small proportion of patients with features of difficult-to-treat nAMD may benefit from supplemental intravitreal anti-VEGF injections and initial close monitoring is recommended.

Financial disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Objective: To differentiate intraretinal fluid (IRF) cysts from degenerative pseudocysts in neovascular age-related macular degeneration (AMD) by quantitative multimodal imaging.

Design: Observational, cross-sectional.

Participants: Patients affected by macular neovascularization secondary to AMD.

Methods: All patients were analyzed by OCT, OCT angiography (OCTA), and dense automatic real-time (ART) OCTA. New-onset cysts were considered IRF, whereas those cysts that were found to be persistent for at least 3 months were categorized as degenerative pseudocysts. Intraretinal cysts were automatically segmented to calculate cyst circularity. Peri-cyst space was quantitatively analyzed to assess the presence of perfusion signal and hyperreflective foci (HF).

Main outcome measures: Best-corrected visual acuity, cyst circularity, peri-cyst perfusion, peri-cyst HF, fibrosis, and outer retinal atrophy.

Results: We analyzed 387 cysts collected from 35 eyes of 35 patients with neovascular AMD (14 men; mean age, 80 ± 5 years). We classified 302 IRF cysts and 85 degenerative pseudocysts. Intraretinal fluid cysts were characterized by significantly higher circularity (0.86; range, 0.81-0.91), perfusion signal in the peri-cyst space, and peri-cyst HF in 89% of cases (all P < 0.05). Degenerative pseudocysts showed significantly lower circularity (0.68; range, 0.64-0.76), no perfusion signal in the peri-cyst space, and peri-cyst HF in only 29% of cases (all P < 0.05). The adopted quantitative metrics significantly correlated with disease duration, number of injections, fibrosis, and outer retinal atrophy.

Conclusions: Intraretinal fluid cysts can be discriminated from degenerative pseudocysts using a quantitative multimodal imaging approach. These findings are clinically relevant and should be included in future training models for artificial intelligence algorithms to improve the diagnostic power and fluid monitoring in neovascular AMD.

Financial disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Purpose: To describe the retinal and vitreous changes in eyes showing myopic macular schisis (MMS) improvement when vitrectomy was not performed and identify triggering factors.

Design: Retrospective observational study.

Subjects: Patients with nonoperated MMS.

Methods: The records of patients with MMS who were followed without performing surgery for >6 months were retrospectively reviewed, and the eyes showing an anatomic improvement were included. Myopic macular schisis evolution was analyzed quantitatively (central foveal thickness [CFT], parafoveal thickness, maximum height) and qualitatively (presence/absence of foveal detachment, lamellar hole, epiretinal membrane, choroidal neovascularization, inner and outer retinoschisis, vitreous status) at baseline and at the final visit. An anatomic improvement was defined as a decrease in CFT by ≥50 μm.

Main outcome measures: The rate of anatomic improvement of MMS without performing vitrectomy and the morphological changes observed in these cases.

Results: In a cohort of 74 nonoperated eyes with MMS, MMS improved in 14 eyes (19%) after a mean follow-up of 55 ± 38 months (range, 8-138). In these improved cases, the mean decrease in CFT was 153 ± 166 μm (range, 24-635; P = 0.005) and a complete resolution of MMS was observed in 9 eyes (64%). In 9 eyes (64%), the improvement was associated with visible vitreous changes in the macular area on the OCT scans. The mean visual acuity, which was already good at baseline (20/50, 0.4 ± 0.2 logarithm of the minimum angle of resolution), increased at the last visit (20/40, 0.3 ± 0.3 logarithm of the minimum angle of resolution) but without reaching significance.

Conclusions: This long-term follow-up analysis showed that almost 20% of MMS in eyes without indication for surgery could improve over time. In most cases, the improvement was associated with an apparent resolution of vitreous tensions.

Financial disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Purpose: To examine the incidence and risk factors of proliferative vitreoretinopathy (PVR) in the patients who develop rhegmatogenous retinal detachment (RRD) in their fellow eye after having a prior RRD complicated by PVR.

Design: Multicenter, retrospective observational study.

Subjects: Eyes with retinal detachment and PVR between 2015 and 2023 were identified through the Vestrum Health Database.

Methods: Risk factors for PVR development, specifically documented PVR in the fellow eye, gender, age, lens status, and presenting and final visual acuity (VA), were evaluated.

Main outcome measures: Odds ratio (OR) for PVR development during 6 months postoperative period.

Results: Of 57 264 patients, 11% had PVR in ≥1 eye. Of the 50 989 patients who did not develop PVR after the initial RRD, 4834 developed RRD in the fellow eye. One hundred sixty-six of these patients developed PVR in their second eye for a PVR rate of 3% in the fellow eye. Of the 6275 patients who developed PVR after primary RRD repair, 406 of these patients went on to develop RRD in their fellow eye. Forty-two of these patients developed PVR in their second eye for a PVR rate of 10%. A regression model that also included age, gender, and VA led to an OR of 3.42 (P < 0.001). The OR of PVR development generally decreased with age. Pseudophakic patients had a higher OR for PVR development, 1.48 (P = 0.017). Initial patients with VA 20/40 to 20/80 had an OR of 2.15 (P = 0.003). Patients with VA worse than 20/200 had an OR of 2.89 for PVR development (P < 0.001).

Conclusions: Patients with a history RRD with PVR in 1 eye have approximately 3.5 times higher rate of PVR in their second eye after RRD compared with patients without a history of PVR. This finding potential impacts surgical decisions and use of prophylactic anti-PVR therapy if the patient's second eye has RRD. The final VA in the second eye of patients with a history of PVR is better than for the second eye of patients with no history of PVR, which may indicate surgeons are already taking steps to prevent PVR in the patient's second eye.

Financial disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.