The need for supplemental ranibizumab in PDS Archway trial patients

Recently, researchers evaluated the safety and efficacy of supplemental ranibizumab injections in eyes with the port delivery system with ranibizumab.

The post hoc analyses of data from the Phase III, randomized, multicenter, open-label active-comparator Archway trial included adults with nAMD diagnosed within nine months of screening previously responsive to anti-VEGF therapy.

A total of 418 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.

Here are some of the findings: 

• Of the 246 eyes treated with the PDS Q24W and assessed for supplemental treatment criteria, the vast majority (94.6 to 98.4 percent) didn’t receive supplemental treatment during each retreatment interval, with 87.4 percent not receiving supplemental treatment at any point during the trial. 

• Of the 31 eyes receiving supplemental treatment, 58.1 percent received one injection and 32.3 percent received two. 

• At baseline, eyes receiving supplemental treatment were significantly more likely to have thicker retinas (mean CST 370.5 vs. 304.4 μm; p=0.0001), subretinal fluid (54.8 vs. 21.2 percent; p<0.0001) and larger pigment epithelial detachment height (215.7 vs. 175.9 μm; p=0.003). These features have previously been associated with difficult-to-treat nAMD. 

• While 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 one line of vision from baseline to week 96, and CST continued to increase over time. 

• Absolute BCVA at week 96 was similar to baseline, irrespective of supplemental treatment status (71.1 and 73.7 letters, respectively). 

• BCVA and CST generally improved within 28 days of supplemental treatment.

Researchers found that, although the Port Delivery System with ranibizumab every 24 weeks effectively maintained vision and retinal stability in most eyes with neovascular age-related macular degeneration, a small proportion of patients with features of difficult-to-treat neovascular age-related macular degeneration may benefit from supplemental intravitreal anti-vascular endothelial growth factor injections, and initial close monitoring is recommended. 

Nielsen JS, Chang A, Holekamp NM, et al. Supplemental intravitreal ranibizumab injections in eyes treated with the PDS with ranibizumab in the Archway trial. Ophthalmol Retina 2024; Jun 22. [Epub ahead of print].

A look at home OCT-guided management of wet AMD

Investigators evaluated the impact of home OCT-guided patient management.

An interventional trial was conducted to compare frequency of treatment and visual acuity for neovascular AMD patients before and during use of home OCT over six months. Patient adherence to regular scanning was measured by the number of scans performed per week. Analysis of fluid recurrence episodes and classification of typical fluid volume trajectories was performed.

Here are some of the findings:

• 27 eyes (21 with nAMD diagnosis and one that converted during the study) of 15 patients were monitored for six months, scanning at 6.2 times/week/eye and yielding 4,435 scans, of which 91.2 percent were eligible for AI-based fluid volume quantification.

• Total number of monitoring weeks prior to the study was 1,555 and during the study was 509.

• The mean number of weeks per injection before OCT management was 8±4.7 and during OCT management was 15.3 ±8.5 (p=0.004).

• The mean VA change before home OCT-based management was 3.5 ±12 letters, and during home OCT-based management was 0.0 ±9.5 letters (p=0.45), showing no significant impact on VA.

Investigators wrote that remote patient monitoring enabled personalized management of wet AMD and significant reduction in treatment burden.

Holekamp NM, de Beus A, Clark WL, et al. Prospective trial of Home OCT guided management of treatment experienced nAMD patients. Retina 2024 May 22. [Epub ahead of print].

Pegcetacoplan Treatment Studied

Despite its advantages for detailed imaging of geographic atrophy, researchers wrote that spectral-domain optical coherence tomography might benefit from automated quantitative OCT analyses in GA diagnosis, monitoring and reporting of its landmark clinical trials.

They analyzed the association between pegcetacoplan and consensus GA SD-OCT endpoints, as part of a post hoc analysis of 11,614 SD-OCT volumes from 936 of 1,258 participants in two parallel Phase III GA studies: OAKS and DERBY. This analysis was conducted from September to December 2023.

Study participants received pegcetacoplan, 15 mg per 0.1 mL intravitreal injection, monthly or every other month, or sham injection monthly or every other month.

The primary endpoint was the least squares mean change from baseline in area of RPE and outer retinal atrophy in each of the three treatment arms (pegcetacoplan monthly, pegcetacoplan every other month, and pooled sham [sham monthly and sham every other month]) at 24 months. 

Among 936 participants, the mean age was 78.5 ±7.22 years; 570 participants (60.9 percent) were female. Here are some of the findings:

• pegcetacoplan monthly: -0.86 mm²; CI, -1.15 to -0.57; p<0.001;

• pegcetacoplan every other month: -0.69 mm²; CI, -0.98 to -0.39; p<0.001).

This association was more pronounced with more frequent dosing (pegcetacoplan monthly vs. every other month at month 24: -0.17 mm²; p=0.17). Stronger associations were observed in the parafoveal and perifoveal regions. RS

Fu DJ, Bagga P, Naik G, et al. Pegcetacoplan treatment and consensus features of geographic atrophy over 24 months. JAMA Ophthalmol 2024; May 9. [Epub ahead of print].