AzTrials
AzTrials

Neovascular Age-Related Macular DegenerationPhase 3ArchwayNCT03677934

A Phase III Study to Evaluate the Port Delivery System With Ranibizumab Compared With Monthly Ranibizumab Injections in Participants With Wet Age-Related Macular Degeneration

A Phase 3 study testing PDS Implant filled with 100 mg/mL Ranibizumab and Intravitreal Injections of 10 mg/mL Ranibizumab in people with Neovascular Age-Related Macular Degeneration, run by Hoffmann-La Roche at 77 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Study GR40548 is a Phase III, randomized, multicenter, open-label (visual assessor [VA]-masked), active-comparator study designed to assess the efficacy, safety, and pharmacokinetics (PK) of 100mg/ml delivered via the Port Delivery System with ranibizumab (PDS) compared with ranibizumab intravitreal injections at 0.5… Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
PDS Implant filled with 100 mg/mL Ranibizumab and Intravitreal Injections of 10 mg/mL Ranibizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
415 participants
Where
77 sitesUnited States
Study dates
12 Sep 2018to 9 Jun 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥50 years, at time of signing Informed Consent Form
  • Initial diagnosis of exudative neovascular age-related macular degeneration (nAMD) within 9 months prior to the screening visit
  • Previous treatment with at least three anti-vascular endothelial growth factor (anti-VEGF) intravitreal injections for nAMD per standard of care within 6 months prior to the screening visit
  • Demonstrated response to prior anti-VEGF intravitreal treatment since diagnosis
  • Best-corrected visual acuity (BCVA) of 34 letters or better

Who cannot join

  • Subfoveal fibrosis or subfoveal atrophy in study eye
  • Subretinal hemorrhage that involves the center of the fovea in study eye
  • History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in study eye
  • Prior treatment with Visudyne®, external-beam radiation therapy, or transpupillary thermotherapy in study eye
  • Previous intraocular device implantation in study eye
  • Previous laser (any type) used for AMD treatment in study eye
Show all 18Show fewer
  • Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit in either eye
  • Prior participation in a clinical trial involving anti-VEGF drugs within 6 months prior to the randomization visit, other than ranibizumab in either eye
  • CNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia in either eye
  • Uncontrolled blood pressure
  • History of stroke within the last 3 months prior to informed consent
  • Uncontrolled atrial fibrillation within 3 months of informed consent
  • History of myocardial infarction within the last 3 months prior to informed consent
  • History of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the Implant and that might affect interpretation of the results of the study or renders the participant at high risk of treatment complications in the opinion of the investigator
  • Current systemic treatment for a confirmed active systemic infection
  • Chronic use of oral corticosteroids
  • Active cancer within 12 months of randomization
  • Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month preceding the informed consent (excluding vitamins and minerals)

Trial locations and contacts

77 sites in 1 country.

77 sites in 1 country

United States77 sites

  • Texas Retina Associates

    Arlington, Texas, 76012

  • Southeast Retina Center

    Augusta, Georgia, 30909

  • Austin Retina Associates

    Austin, Texas, 78705

  • Austin Clinical Research LLC

    Austin, Texas, 78750

  • California Retina Consultants

    Bakersfield, California, 93309

  • The Retina Care Center

    Baltimore, Maryland, 21209

  • Johns Hopkins Med; Wilmer Eye Inst

    Baltimore, Maryland, 21287

  • Retina Consultants of Texas

    Bellaire, Texas, 77401

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, California, 90211

  • Envision Ocular, LLC

    Bloomfield, New Jersey, 07003

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02114

  • Char Eye Ear &Throat Assoc

    Charlotte, North Carolina, 28210

  • Mid Atlantic Retina - Wills Eye Hospital

    Cherry Hill, New Jersey, 08034

  • Midwest Vision Research Foundation

    Chesterfield, Missouri, 63017

  • The Retina Institute - Chesterfield

    Chesterfield, Missouri, 63017

  • Retina Group of Washington

    Chevy Chase, Maryland, 20815

  • Cincinnati Eye Institute

    Cincinnati, Ohio, 45242

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • OSU Eye Physicians & Surgeons

    Columbus, Ohio, 43212

  • Southwest Retina Consultants

    Durango, Colorado, 81303

  • VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota

    Edina, Minnesota, 55435

  • Retina Vitreous Center

    Edmond, Oklahoma, 73013

  • The Retina Partners

    Encino, California, 91436

  • Palmetto Retina Center

    Florence, South Carolina, 29501

  • Eye Center of Northern CO

    Fort Collins, Colorado, 80528

  • National Ophthalmic Research Institute

    Fort Myers, Florida, 33912

  • Texas Retina Associates

    Fort Worth, Texas, 76104

  • Associated Retinal Consultants

    Grand Rapids, Michigan, 49546

  • Foundation for Vision Research

    Grand Rapids, Michigan, 49546

  • Long Is. Vitreoretinal Consult

    Great Neck, New York, 11021

  • Illinois Retina Associates

    Joliet, Illinois, 60435

  • Colorado Retina Associates, PC

    Lakewood, Colorado, 80228

  • University Retina and Macula Associates, PC

    Lemont, Illinois, 60439

  • Retina Associates

    Lenexa, Kansas, 66215

  • Retina Associates of Kentucky

    Lexington, Kentucky, 40509

  • Retina Vit Surgeons/Central NY

    Liverpool, New York, 13088

  • Jules Stein Eye Institute/ UCLA

    Los Angeles, California, 90095-7000

  • Georgia Retina PC

    Marietta, Georgia, 30060

  • Florida Eye Associates

    Melbourne, Florida, 32901

  • Charles Retina Institute

    Memphis, Tennessee, 38119

  • Barnet Dulaney Perkins Eye Center

    Mesa, Arizona, 85206

  • N CA Retina Vitreous Assoc

    Mountain View, California, 94040

  • Tennessee Retina PC

    Nashville, Tennessee, 37203

  • Vitreous-Retina-Macula

    New York, New York, 10022

  • Wagner Macula & Retina Center

    Norfolk, Virginia, 23502

  • Paducah Retinal Center

    Paducah, Kentucky, 42001

  • Retina Care Specialists

    Palm Beach Gardens, Florida, 33410

  • Retina Specialty Institute

    Pensacola, Florida, 32503

  • Associated Retina Consultants

    Phoenix, Arizona, 85020

  • Arizona Retina and Vitreous Consultants

    Phoenix, Arizona, 85021

  • Retinal Consultants of Arizona

    Phoenix, Arizona, 85053

  • Fort Lauderdale Eye Institute

    Plantation, Florida, 33324

  • Maine Eye Center

    Portland, Maine, 04101

  • Retina Northwest

    Portland, Oregon, 97221

  • Retina Consultants, San Diego

    Poway, California, 92064

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • Retina Institute of Virginia

    Richmond, Virginia, 23235

  • Ophthalmic Consultants of Long Island

    Rockville Centre, New York, 11570

  • Retinal Consultants Med Group

    Sacramento, California, 95825

  • Retina Associates of Utah

    Salt Lake City, Utah, 84107

  • Rocky Mountain Retina

    Salt Lake City, Utah, 84107

  • Med Center Ophthalmology Assoc

    San Antonio, Texas, 78240

  • West Coast Retina Medical Group

    San Francisco, California, 94109

  • UCSF; Ophthalmology

    San Francisco, California, 94143

  • Orange County Retina Med Group

    Santa Ana, California, 92705

  • California Retina Consultants

    Santa Barbara, California, 93103

  • Retina Center Northwest

    Silverdale, Washington, 98383

  • Spokane Eye Clinical Research

    Spokane, Washington, 99204

  • Retina Vitreous Assoc of FL

    St. Petersburg, Florida, 33711

  • Southern Vitreoretinal Assoc

    Tallahassee, Florida, 32308

  • Retina Associates of Florida, LLC

    Tampa, Florida, 33609

  • NJ Retina Teaneck Clinic

    Toms River, New Jersey, 08755

  • Retina Specialists

    Towson, Maryland, 21204

  • Bay Area Retina Associates

    Walnut Creek, California, 94598

  • Retina Group of New England

    Waterford, Connecticut, 06385

  • Wolfe Eye Clinic

    West Des Moines, Iowa, 50266

  • Vitreo-Retinal Associates, PC

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: Phase III, Multicenter, Randomized, Visual Assessor-Masked, Active-Comparator Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration

Study GR40548 is a Phase III, randomized, multicenter, open-label (visual assessor [VA]-masked), active-comparator study designed to assess the efficacy, safety, and pharmacokinetics (PK) of 100mg/ml delivered via the Port Delivery System with ranibizumab (PDS) compared with ranibizumab intravitreal injections at 0.5 mg (10 mg/mL) in participants with neovascular age-related macular degeneration (nAMD).

Being tested
PDS Implant filled with 100 mg/mL Ranibizumab, Intravitreal Injections of 10 mg/mL Ranibizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PDS Implant filled with 100 mg/mL RanibizumabDrug

    Will be administered as per the schedule described in individual arm.

  • Intravitreal Injections of 10 mg/mL RanibizumabDrug

    Will be administered as per the schedule described in individual arm.

Study groups in NCT03677934
Study groupRoleWhat they receive
PDS Implant ArmExperimentalParticipants will receive ranibizumab delivered through the PDS implant with 100 mg/mL in the study eye on Day 1 and receive refill-exchanges at fixed 24-week intervals
Receives: Drug: PDS Implant filled with 100 mg/mL Ranibizumab
Intravitreal ArmActive comparatorParticipants will receive ranibizumab 0.5 mg monthly intravitreal injections of 10 mg/mL formulation at Day 1 and every month thereafter.
Receives: Drug: Intravitreal Injections of 10 mg/mL Ranibizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Best-Corrected Visual Acuity (BCVA) Score at the Average of Week 36 and Week 40, as Assessed Using the ETDRS Visual Acuity Chart at a Starting Distance of 4 Meters

    The primary efficacy endpoint is the change in BCVA score from baseline averaged over Weeks 36 and 40 with BCVA assessed using the ETDRS chart at a starting distance of 4 meters. ETDRS = Early Treatment Diabetic Retinopathy Study.

    The primary objective is to determine the NI and equivalence between the two treatment groups, as measured by the primary efficacy endpoint with a NI margin of 4.5 letters and equivalence margins of ± 4.5 letters.

    A vision score of 20/20 vision is considered normal. A score of 20/200 is considered being legally blind.

    Measured: Baseline, and the average of Week 36 and Week 40

Secondary outcomes (22)

  1. Change From Baseline in BCVA Score Averaged Over Week 60 and Week 64

    Measured: Baseline, Week60, Week 64

  2. Change From Baseline in BCVA Score Over Time

    Measured: Baseline up to Week 96

  3. Percentage of Participants With BCVA Score of 38 Letters (20/200 Approximate Snellen Equivalent) or Worse at the Average Over Week 36 and Week 40

    Measured: Baseline, and the average of Week 36 and Week 40

  4. Percentage of Participants With BCVA Score of 38 Letters (20/200 Approximate Snellen Equivalent) or Worse Over Time

    Measured: Baseline up to Week 96

  5. Percentage of Participants With BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better at the Average Over Week 36 and Week 40

    Measured: Baseline, and the average of Week 36 and Week 40

  6. Percentage of Participants With BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better Over Time

    Measured: Baseline up to Week 96

  7. Percentage of Participants Who Lose <10 or <5 Letters in BCVA Score From Baseline to the Average Over Week 36 and Week 40

    Measured: Baseline, and the average of Week 36 and Week 40

  8. Percentage of Participants Who Lose <10 or <5 Letters in BCVA Score From Baseline Over Time

    Measured: Baseline up to Week 96

  9. Percentage of Participants Who Gain ≥0 Letters in BCVA Score From Baseline to the Average Over Week 36 and Week 40

    Measured: Baseline up to Week 40

  10. Percentage of Participants Who Gain ≥0 Letters in BCVA Score From Baseline Over Time

    Measured: Baseline up to Week 96

  11. Change From Baseline in Center Point Thickness (CPT) at Week 36

    Measured: Baseline to Week 36

  12. Change From Baseline in CPT Over Time

    Measured: Baseline up to Week 96

  13. Percentage of Participants in the PDS Implant Arm Who Undergo Supplemental Treatment With Intravitreal Ranibizumab 0.5 mg Before the First, Second, Third, and Fourth Fixed Refill-Exchange Intervals

    Measured: Day 1 to Week 24, Week 25 to Week 48, Week 49 to Week 72, Week73 to Week 96

  14. Percentage of Participants in the PDS Implant Arm Who Undergo a Supplemental Treatment That Requires Subsequent Additional Supplemental Treatments During the Study

    Measured: Week 16 to Week 92

  15. Percentage of Participants With Ocular and Systemic (Non-Ocular) AEs

    Measured: Randomization to Week 96

  16. Percentage of Participants With Adverse Events of Special Interest

    Percentage of Participants with Adverse Events of Special Interest

    Measured: Randomization to Week 96

  17. Observed Serum Ranibizumab Concentrations at Specified Timepoints

    Measured: Randomization to Week 96

  18. Estimated PK Parameter Values AUC0-6M

    AUC0-6M = Area Under the Concentration-Time Curve From 0 to 6 Months

    Measured: Randomization to Week 96

  19. Estimated PK Parameter Value t1/2 After PDS Implant Insertion

    Apparent terminal half-life

    Measured: Randomization to Week 96

  20. Estimated PK Parameter Value Cmin

    Cmin = Minimum Serum Concentration

    Measured: Randomization to Week 96

  21. Estimated PK Parameter Value Cmax

    Cmax = Maximum Serum Concentration

    Measured: Randomization to Week 96

  22. Baseline Prevalence and Incidence of Treatment-Emergent ADA

    Measured: Randomization to Week 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2018
  2. Study start12 Sep 2018
  3. Primary completion22 May 2020
  4. Study completion9 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
415 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03677934
Sponsor's protocol ID
GR40548
Acronym
Archway
Status last verified
Sep 2022
First submitted
11 Sep 2018
Last updated
4 Oct 2022
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).

Publications

  • Maass KF, Maia M, Gune S, Chang MC. Pharmacodynamics of Free VEGF After Treatment with the Port Delivery Platform with Ranibizumab in Patients with Neovascular Age-Related Macular Degeneration. Ophthalmol Sci. 2026 Aug 17;6(10):101367. doi: 10.1016/j.xops.2026.101367. eCollection 2026 Oct.

    PubMed 42787488

  • Chakravarthy U, Gemmy Cheung CM, Staurenghi G, Sadda S, Guymer R, Jaffe GJ, Curcio CA, Holekamp NM, Bachmeier I, Scherb MP, Blotner S, Rabena M, Cordeiro MC, Armendariz BG, Kanku MS, Heinrich D. Low Rates of Fibrosis in Eyes Treated with the Port Delivery Platform with Ranibizumab or with Monthly Ranibizumab in the Archway Trial. Ophthalmol Sci. 2026 Jun 8;6(8):101276. doi: 10.1016/j.xops.2026.101276. eCollection 2026 Aug.

    PubMed 42473439

  • Sheth VS, Holekamp NM, Khanani AM, Rachitskaya A, Blotner S, Gune S, Heinrich D, Maass KF, Chakravarthy U. Retinal Fluid and Thickness Fluctuations in Archway Trial for Port Delivery System with Ranibizumab versus Monthly Ranibizumab Injections. Ophthalmol Retina. 2025 Apr;9(4):330-342. doi: 10.1016/j.oret.2024.10.015. Epub 2024 Oct 22.

    PubMed 39447871

  • Campochiaro PA, Eichenbaum D, Chang MA, Clark WL, Graff JM, Le Pogam S, Cavichini Cordeiro M, Gune S, Rabena M, Singh N, Lin S, Callaway N. Interim Results of the Phase III Portal Extension Trial of the Port Delivery System with Ranibizumab in Neovascular Age-Related Macular Degeneration. Ophthalmol Retina. 2025 Feb;9(2):144-155. doi: 10.1016/j.oret.2024.05.021. Epub 2024 Aug 30.

    PubMed 39209113

  • Eichenbaum DA, Freeman WR, Chang MA, Brooks L, Chaudhry N, Dadgostar H, McCannel CA, Michels M, Mittra RA, Wolfe JD, Beindl VC, Jaycock P, Bobbala A, Gune S, Spicer G, Callaway N. Endophthalmitis in Eyes Treated with the Port Delivery System with Ranibizumab: Summary of Cases during Clinical Trial Development. Ophthalmol Retina. 2025 Feb;9(2):127-143. doi: 10.1016/j.oret.2024.08.005. Epub 2024 Aug 16.

    PubMed 39154860

  • Nielsen JS, Chang A, Holekamp NM, Cavichini-Cordeiro M, Lin SL, Heinrich D, Maass KF, Menezes A, Singh N, Pieramici DJ. Supplemental Intravitreal Ranibizumab Injections in Eyes Treated with the Port Delivery System with Ranibizumab in the Archway Trial. Ophthalmol Retina. 2024 Dec;8(12):1127-1139. doi: 10.1016/j.oret.2024.06.012. Epub 2024 Jun 22.

    PubMed 38914294

  • Chang MA, Kapre A, Kaufman D, Kardatzke DR, Rabena M, Patel S, Bobbala A, Gune S, Fung A, Wallenstein G. Patient Preference and Treatment Satisfaction With a Port Delivery System for Ranibizumab vs Intravitreal Injections in Patients With Neovascular Age-Related Macular Degeneration: A Randomized Clinical Trial. JAMA Ophthalmol. 2022 Aug 1;140(8):771-778. doi: 10.1001/jamaophthalmol.2022.1091.

    PubMed 35708706

  • Awh CC, Barteselli G, Makadia S, Chang RT, Stewart JM, Wieland MR, Brassard R, Callaway NF, Gune S, Heatherton P, Malhotra V, Willis JR, Pieramici DJ. Management of Key Ocular Adverse Events in Patients Implanted with the Port Delivery System with Ranibizumab. Ophthalmol Retina. 2022 Nov;6(11):1028-1043. doi: 10.1016/j.oret.2022.05.011. Epub 2022 May 16.

    PubMed 35589078

  • Heimann F, Barteselli G, Brand A, Dingeldey A, Godard L, Hochstetter H, Schneider M, Rothkegel A, Wagner C, Horvath J, Ranade S. A custom virtual reality training solution for ophthalmologic surgical clinical trials. Adv Simul (Lond). 2021 Apr 16;6(1):12. doi: 10.1186/s41077-021-00167-z.

    PubMed 33863399

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PDS Implant filled with 100 mg/mL Ranibizumab and Intravitreal Injections of 10 mg/mL Ranibizumab in people with Neovascular Age-Related Macular Degeneration, run by Hoffmann-La Roche at 77 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Best-Corrected Visual Acuity (BCVA) Score at the Average of Week 36 and Week 40, as Assessed Using the ETDRS Visual Acuity Chart at a Starting Distance of 4 Meters (time frame: Baseline, and the average of Week 36 and Week 40). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03677934, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022; AzTrials last refreshed its copy on 30 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in