Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Ranibizumab for Neovascular Age-related Macular Degeneration

This study wants to measure the effectiveness, safety, and PROs of the port delivery system with ranibizumab 100 milligrams/milliliters (mg/mL) refilled every 36 weeks (Q36W) in participants with nAMD.

Official registry: https://clinicaltrials.gov/study/NCT06847542 · Hoffmann-La Roche · enrollment listed as 250

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Susvimo PDS Implant, or Ranibizumab. The registry lists allocation as na. This study wants to measure the effectiveness, safety, and PROs of the port delivery system with ranibizumab 100 milligrams/milliliters (mg/mL) refilled every 36 weeks (Q36W) in participants with nAMD.

They plan to enroll about 250 people at 64 sites. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.

Official title (unrewritten)

A Phase IIIb, Multicenter, Single-arm Study Assessing the Effectiveness, Safety and Patient Reported Outcomes of a 36-week Refill Exchange Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-related Macular Degeneration

Interventions: Susvimo PDS Implant, Ranibizumab

Primary outcome (registry wording): Change From Baseline in Best Corrected Visual Acuity (BCVA) Score Averaged Over Weeks 68 and 72, as Assessed Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at a Starting Distance of 4 Meters

Who it is for (from inclusion criteria)

  • Ages 50 Years to any
  • Initial diagnosis of nAMD within 24 months prior to screening
  • Previous treatment with at least 3 anti-vascular endothelial growth factor (VEGF) IVT injections for nAMD per standard of care within 6 months prior to screening
  • Demonstrated response to prior anti-VEGF IVT treatment since diagnosis
  • Availability of historical VA data obtained at or after nAMD diagnosis and prior to the first anti-VEGF treatment for nAMD
  • Availability of historical OCT image data obtained at or after nAMD diagnosis and prior to the first anti-VEGF treatment for nAMD
  • BCVA of 34 letters or better using ETDRS chart at a starting distance of 4 meters at screening and enrollment visits

Public study contact (from the registry)

Reference Study ID Number: MR45625 https://forpatients.roche.com/ No attachments to email below.

888-662-6728 (U.S.)

global-roche-genentech-trials@gene.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

64 listed

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phaseBethesda, Maryland
Cell Collection to Study Eye Diseases

Background: \- Best Vitelliform Dystrophy (Best disease), Late-Onset Retinal Degeneration (L-ORD), and Age-Related Macular Degeneration (AMD) all affect the retina, the light sensing area at the back of the eye. Doctors cannot safely obtain retinal cells to study these diseases.

NCT01432847 · Official ClinicalTrials.gov record · National Eye Institute (NEI)

RecruitingPhase 3Phoenix, Arizona
Phase 3: testing PDS Implant with Ranibizumab 100 mg/mL for Neovascular Age-Related Macular Degeneration

This study will measure the long-term whether it is safe and how hard side effects are to live with of the Port Delivery System with ranibizumab (PDS) (100 mg/mL) in participants with neovascular age-related macular degeneration (nAMD) who have either completed Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway), Phase IIIb Study WR42221 (Velodrome), or completed Week 24 visit in Study WR42221 but were not eligible to be randomly assigned in WR42221.

NCT03683251 · Official ClinicalTrials.gov record · Hoffmann-La Roche

FAQ about this NCT record

Is NCT06847542 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06847542?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06847542?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary