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Neovascular Age-related Macular DegenerationPhase 3HUTONGNCT05562947

A Study of the Efficacy, Safety, and Pharmacokinetics (PK) of the Port Delivery System With Ranibizumab (PDS) in Chinese Participants With Neovascular Age-related Macular Degeneration (nAMD)

A Phase 3 study testing PDS With Ranibizumab (100 mg/mL) and Ranibizumab (10 mg/mL) in people with Neovascular Age-related Macular Degeneration and nAMD, run by Hoffmann-La Roche at 14 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study will evaluate the efficacy, safety, and PK of ranibizumab 100 milligrams per milliliter (mg/mL) delivered every 24 weeks (Q24W) via the PDS implant compared with ranibizumab 0.5 milligrams (mg) delivered every 4 weeks (Q4W) as intravitreal (IVT) injection in Chinese participants with nAMD. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
PDS With Ranibizumab (100 mg/mL) and Ranibizumab (10 mg/mL)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
14 sitesChina
Study dates
17 Jun 2024to 31 Jul 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Initial diagnosis of nAMD within 9 months prior to the screening visit
  • Previous treatment with at least three anti-vascular endothelial growth factor (VEGF) IVT injections for nAMD per standard-of-care (SOC) within 6 months prior to the screening visit
  • Demonstrated response to prior anti-VEGF IVT treatment since diagnosis
  • Availability of historical VA data prior to the first anti-VEGF treatment for nAMD up to the screening visit
  • BCVA of 34 letters or better (20/200 or better approximate Snellen equivalent), using Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters
  • All subtypes of nAMD lesions are permissible
  • Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by the central reading center of fundus photography (FP), fluorescein angiography (FA), indocyanine green angiography (ICGA), fundus autofluorescence (FAF), and optical coherence tomography (OCT) images

Who cannot join

  • Prior Ocular Treatment Study Eye
  • History of vitrectomy surgery, submacular surgery, or other surgical intervention, all for AMD
  • Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy
  • Previous treatment with corticosteroid IVT injection or corticosteroid implants
  • Previous intraocular device implantation (not including intraocular lens implants)
  • Previous laser (any type) used for age-related macular degeneration (AMD) treatment
Show all 38Show fewer
  • Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit
  • Prior treatment with IVT treatments for geographic atrophy
  • Concurrent conjunctival, Tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye that may affect the implantation, subsequent tissue coverage, and refill-exchange procedure of the PDS implant
  • Either Eye
  • Prior treatment with brolucizumab
  • Prior gene therapy for nAMD or other ocular diseases
  • Previous participation in any ocular disease studies of investigational drugs and/or devices, within 3 months or five elimination half-lives of the investigational therapy, whichever is longer, preceding the screening visit
  • Choroidal Neovascularization (CNV) Lesion Characteristics
  • Study Eye
  • Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5 disc area (1.27 millimeter square [mm^2]) in size at screening
  • Subfoveal fibrosis or subfoveal atrophy
  • Either Eye • CNV due to other causes, such as ocular histoplasmosis, trauma, central serous chorio-retinopathy, or pathologic myopia
  • Concurrent Ocular Conditions Study Eye
  • Retinal pigment epithelial tear
  • Any concurrent intraocular condition
  • Active intraocular inflammation (grade trace or above)
  • History of vitreous hemorrhage
  • History of rhegmatogenous retinal detachment
  • History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the randomization visit
  • History of pars plana vitrectomy surgery
  • Aphakia or absence of the posterior capsule
  • Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia
  • Preoperative refractive error that exceeds 8 diopters of myopia, for participants who have undergone prior refractive or cataract surgery
  • Intraocular surgery (including cataract surgery) within 3 months preceding the randomization visit
  • Uncontrolled ocular hypertension or glaucoma
  • History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery
  • History of corneal transplant
  • Fellow (Non-Study) Eye
  • Non-functioning fellow eye
  • Either Eye
  • Any history of uveitis
  • Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

China14 sites

  • Peking Union Medical College Hospital

    Beijing, 100032

  • Beijing Tongren Hospital

    Beijing, 100730

  • West China Hospital, Sichuan University

    Chengdu, 610041

  • Sichuan Provincial People's Hospital

    Chengdu, 610072

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou, 510060

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, 150081

  • Qingdao Eye Hospital of Shandong First Medical University

    Qingdao, 266109

  • Shanghai First People's Hospital

    Shanghai, 200080

  • The First Affiliated Hospital of China Medical University

    Shenyang, 110001

  • Shanxi Eye Hospital

    Taiyuan, 030002

  • Tianjin Medical University Eye Hospital

    Tianjin, 300070

  • Eye Hospital, Wenzhou Medical University

    Wenzhou, 325027

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430030

  • Xi'an People's Hospital (Xi'an Fourth Hospital)

    Xi'an

Other trials in China

About this study

Official title: A Phase III, Multicenter, Randomized, Visual Assessor-masked, Active-comparator Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Chinese Patients With Neovascular Age-related Macular Degeneration

This study will evaluate the efficacy, safety, and PK of ranibizumab 100 milligrams per milliliter (mg/mL) delivered every 24 weeks (Q24W) via the PDS implant compared with ranibizumab 0.5 milligrams (mg) delivered every 4 weeks (Q4W) as intravitreal (IVT) injection in Chinese participants with nAMD.

Being tested
PDS With Ranibizumab (100 mg/mL), Ranibizumab (10 mg/mL)

What participants receive

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

  • PDS With Ranibizumab (100 mg/mL)Device

    Participants randomized to the implant arm will have the implant (filled prior to implantation with approximately 20 microliters (μL) of the 100 mg/mL formulation of ranibizumab [approximately 2 mg dose of ranibizumab]) surgically inserted in the study eye at the Day 1 visit following their randomization visit, or at Week 48 visit for participants randomized to the IVT arm. After the initial fill of the implant with ranibizumab, participants will receive implant refill-exchanges at fixed 24-week intervals.

  • Ranibizumab (10 mg/mL)Drug

    Participants in the IVT arm will receive their first IVT injection of 50 μL of the 10 mg/mL ranibizumab (0.5 mg dose) at the Day 1 visit, which will occur at the conclusion of the randomization visit. Afterwards, participants will receive IVT ranibizumab injections of 50 μL of the 10 mg/mL formulation Q4W at each scheduled study visit until Week 44 and bi-monthly visits thereafter, followed by visits every two months until study completion.

Study groups in NCT05562947
Study groupRoleWhat they receive
Implant ArmExperimentalParticipants will have the implant (pre-filled intraoperatively with ranibizumab 100 mg/mL) surgically inserted on Day 1. After Day 1, participants in the implant arm will attend monthly study visits, and receive implant refill-exchanges with ranibizumab 100 mg/mL at Week 24 and Week 48. At the Week 48 study visit, participants will move to the long -term extension phase of the study and continue receiving refill-exchanges Q24W until the end of study. Participants will attend monthly visits up to Week 96 and bi-monthly visits thereafter, followed by visits every two months until study completion.
Receives: Device: PDS With Ranibizumab (100 mg/mL)
IVT ArmExperimentalParticipants will receive IVT ranibizumab 0.5 mg injections starting on Day 1. Participants will receive IVT ranibizumab 0.5 mg Q4W until Week 44. At the Week 48 study visit, participants will receive the PDS implant (pre-filled intraoperatively with ranibizumab 100 mg/mL), move to the long-term extension phase of the study and receive Q24W refill exchanges until the end of study. If participants are unable to attend the Week 48 visit due to extenuating circumstances, they should return no later than the next scheduled visit (Week 52), when they will receive the PDS implant. Participants will attend monthly visits up to Week 96 and bi-monthly visits thereafter, followed by visits every two months until study completion.
Receives: Device: PDS With Ranibizumab (100 mg/mL); Drug: Ranibizumab (10 mg/mL)

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 Averaged Over Weeks 36 and 40, as Assessed Using the ETDRS Visual Acuity (VA) Chart at a Starting Distance of 4 Meters

    Measured: Baseline up to Week 40

Secondary outcomes (29)

  1. Change From Baseline in BCVA Score Over Time

    Measured: Baseline up to Week 144

  2. Proportion of Participants With BCVA Score of 38 Letters (20/200 Approximate Snellen Equivalent) or Worse Averaged Over Weeks 36 and 40

    Measured: Baseline up to Week 40

  3. Proportion of Participants With BCVA Score of 38 Letters (20/200 Approximate Snellen Equivalent) or Worse Averaged Over Weeks 44 and 48

    Measured: Baseline up to Week 48

  4. Proportion of Participants With BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better Averaged over Weeks 36 and 40

    Measured: Baseline up to Week 40

  5. Proportion of Participants With BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better Averaged Over Weeks 44 and 48

    Measured: Baseline up to Week 48

  6. Proportion of Participants Who Gain ≥ 0 Letters in BCVA Score From Baseline Averaged Over Weeks 36 and 40

    Measured: Baseline up to Week 40

  7. Proportion of Participants Who Gain ≥ 0 Letters in BCVA Score From Baseline Averaged Over Weeks 44 and 48

    Measured: Baseline up to Week 48

  8. Proportion of Participants Who Lose < 10 or < 5 Letters in BCVA Score From Baseline Averaged Over Weeks 36 and 40

    Measured: Baseline up to Week 40

  9. Proportion of Participants Who Lose < 10 or < 5 Letters in BCVA Score From Baseline Averaged Over Weeks 44 and 48

    Measured: Baseline up to Week 48

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

    CPT is retinal thickness in the center point of the fovea measured between the internal limiting membrane and the inner third of the retinal pigment epithelium layer. CPT will be measured using optical coherence tomography (OCT).

    Measured: Baseline and Week 36

  11. Change From Baseline in Central Subfield Thickness (CST) at Week 36

    CST is defined as the average thickness of the central 1 millimeter (mm) circle of the ETDRS grid centered on the fovea. CST will be measured using OCT.

    Measured: Baseline and Week 36

  12. Change From Baseline in CPT at Week 44

    CPT is retinal thickness in the center point of the fovea measured between the internal limiting membrane and the inner third of the retinal pigment epithelium layer. CPT will be measured using OCT.

    Measured: Baseline and Week 44

  13. Change From Baseline in CST at Week 44

    CST is defined as the average thickness of the central 1 mm circle of the ETDRS grid centered on the fovea. CST will be measured using OCT.

    Measured: Baseline and Week 44

  14. Proportion of Participants in the Implant Arm Who do not Undergo Supplemental Treatment With IVT Ranibizumab 0.5 mg Before the First, Second, Third, Fourth, Fifth, and Sixth Fixed Refill-exchange Intervals

    Measured: Baseline up to 144 weeks

  15. Proportion of Participants in the Implant Arm Who do not Undergo a Supplemental Treatment that Requires Subsequent Additional Supplemental Treatments During the Study

    Measured: Baseline up to 144 weeks

  16. Percentage of Participants With Adverse Events (AEs)

    Measured: Baseline up to 144 weeks

  17. Percentage of Participants With Adverse Events of Special Interest (AESIs)

    Measured: Baseline up to 144 weeks

  18. Duration of AESIs

    Measured: Baseline up to 144 weeks

  19. Percentage of Participants With Ocular AESIs During the Post-operative Period and Follow-up Period

    Measured: Post-operative period: up to 37 days after initial implantation Follow-up period: > 37 days after implantation surgery (up to 144 weeks)

  20. Percentage of Participants Who Received PDS Affected With Adverse Device Effects (ADEs)

    Measured: Baseline up to 144 weeks

  21. Percentage of Participants Who Received PDS Affected With Anticipated Serious Adverse Device Effects (ASADEs)

    Measured: Baseline up to 144 weeks

  22. Duration of ASADEs

    Measured: Baseline up to 144 weeks

  23. Number of Device Deficiencies

    Measured: Baseline up to 144 weeks

  24. Observed Serum Ranibizumab Concentrations at Specified Timepoints

    Measured: Implant Arm: Weeks 4, 12, 24, 28, 36, 48, 96, 144 and early study termination (EST) visit; IVT Arm: Weeks 4, 24, 36, 48, 52, 60, 72, 76, 84, 96, 144 & EST visit (up to 156 weeks)

  25. Area Under the Concentration Time Curve (AUC) From 0-24 Weeks

    Measured: Baseline, Weeks 4, 12, and 24

  26. Maximum Serum Concentration (Cmax) of Ranibizumab

    Measured: Implant Arm: Weeks 4, 12, 24, 28, 36, 48, 96, 144 & EST visit; IVT Arm: Weeks 52, 60, 72, 76, 84, 96, 144, & EST visit (up to 156 weeks)

  27. Minimum Serum Concentration (Cmin) of Ranibizumab

    Measured: Implant Arm: Weeks 4, 12, 24, 28, 36, 48, 96, 144, & EST visit; IVT Arm: Weeks 52, 60, 72, 76, 84, 96, 144, & EST visit (up to 156 weeks)

  28. Number of Participants With Anti-drug Antibodies (ADAs) to Ranibizumab

    Measured: Implant Arm: Baseline; Weeks 4, 24, 36, 48, 96, 144 & EST visit; IVT Arm: Baseline, Weeks 4, 24, 36, 48, 52, 72, 96, 144 & EST visit (up to 156 weeks)

  29. Number of Participants With Treatment-emergent ADAs to Ranibizumab During the Study

    Measured: Implant Arm: Weeks 4, 24, 36, 48, 96, 144, & EST visit; IVT Arm: Weeks 4, 24, 36, 48, 52, 72, 96, 144, & EST visit (up to 156 weeks)

Timeline

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

  1. First posted3 Oct 2022
  2. Study start17 Jun 2024
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Jul 2029 (estimated)

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
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05562947
Sponsor's protocol ID
YR42983
Acronym
HUTONG
Status last verified
Aug 2026
First submitted
15 Sep 2022
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PDS With Ranibizumab (100 mg/mL) and Ranibizumab (10 mg/mL) in people with Neovascular Age-related Macular Degeneration and nAMD, run by Hoffmann-La Roche at 14 sites in China.

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 7 inclusion and 38 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: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in China. 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?

This study is still under way. Results are not available in the source record yet.

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 Averaged Over Weeks 36 and 40, as Assessed Using the ETDRS Visual Acuity (VA) Chart at a Starting Distance of 4 Meters (time frame: Baseline up to 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 NCT05562947.

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 1 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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