• Profile
Close

Refillable ranibizumab device shows promising phase 2 efficacy

American Academy of Ophthalmology News Aug 21, 2019

Researchers assessed the safety and efficacy of the ranibizumab Port Delivery System (PDS) for neovascular AMD.

Study design

This phase 2, multicenter, randomized, active treatment-controlled clinical trial enrolled 220 patients within 9 months of their original diagnosis who were responsive to previous anti-VEGF injections. Patients were randomized to receive PDS with 10 mg/mL (n=58), 40 mg/mL (n=62), or 100 mg/mL (n=59) of ranibizumab or monthly ranibizumab injections (n=41).

Outcomes

The median time to first implant refill in the 10 mg/mL, 40 mg/mL, and 100 mg/mL arms was 8.7, 13.0, and 15.0 months, respectively. The decision to refill was based on prespecified criteria indicating disease activity.

By month 9, the mean BCVA change from baseline was -3.2, -0.5, +5.0, and +3.9 letters in the PDS 10 mg/mL, 40 mg/mL, 100 mg/mL, and monthly ranibizumab arms, respectively. Changes in central foveal thickness from baseline was similar between the PDS 100 mg/mL and monthly ranibizumab arms. Overall, the implantation and refill procedures were well tolerated.

Limitations

This was a promising phase 2 study, but a phase 3 trial is necessary to confirm safety and efficacy. Given the surgical nature of this device, there may be an increased risk of ocular adverse events compared with intravitreal injections. For example, vitreous hemorrhage occurred in 10.1% of patients, but the rate dropped to 4.5% after a modification to the surgical procedure. Three eyes had endophthalmitis and 5 had retinal detachment.

Clinical significance

The race is on for long-acting therapies for wet AMD, diabetic retinopathy, diabetic macular edema, and retinal vein occlusion. The PDS may transform the clinical landscape from frequent injections to more of a surgical implantation scenario that reduces the frequency of office-based therapies. The phase 3 ARCHWAY clinical trial is currently underway and has recently completed enrollment.

Go to Original
Only Doctors with an M3 India account can read this article. Sign up for free or login with your existing account.
4 reasons why Doctors love M3 India
  • Exclusive Write-ups & Webinars by KOLs

  • Nonloggedininfinity icon
    Daily Quiz by specialty
  • Nonloggedinlock icon
    Paid Market Research Surveys
  • Case discussions, News & Journals' summaries
Sign-up / Log In
x
M3 app logo
Choose easy access to M3 India from your mobile!


M3 instruc arrow
Add M3 India to your Home screen
Tap  Chrome menu  and select "Add to Home screen" to pin the M3 India App to your Home screen
Okay