Actively Recruiting
A Phase IIIb Study Evaluating a 36-Week Refill Schedule of the Port Delivery System With Ranibizumab in Patients With Neovascular Age-related Macular Degeneration
Led by Hoffmann-La Roche · Updated on 2026-05-26
250
Participants Needed
57
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Hoffmann-La Roche
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the port delivery system (PDS) with ranibizumab, a drug used to treat neovascular age-related macular degeneration (nAMD). This study evaluates how well the PDS works and its safety, along with patient-reported outcomes. The focus is on a 36-week refill schedule for the PDS implant delivering ranibizumab to participants with nAMD. This Phase IIIb, multicenter study aims to better understand this treatment approach for patients with this eye condition. Participants will have the PDS implant surgically inserted in the study eye on Day 1. The implant is pre-filled with ranibizumab at a concentration of 100 mg/mL, delivering about a 2-milligram dose. Those who show signs of disease activity or receive supplemental ranibizumab injections before Week 24 will have refill exchanges every 24 weeks. Others will have refill exchanges every 36 weeks. The treatments include the implant and supplemental intravitreal ranibizumab injections if needed. During the study, participants will undergo assessments including measuring their best corrected visual acuity using the ETDRS chart at multiple timepoints, especially around Weeks 68 and 72. Researchers will also monitor eye thickness and the need for additional treatments. Patient preferences and adverse events related to the implant and drug will be tracked for up to about 19 months. This thorough monitoring helps evaluate both the safety and effectiveness of the PDS with ranibizumab over time.
CONDITIONS
Brief Title
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with neovascular age-related macular degeneration within 24 months before screening
- Received at least 3 anti-VEGF intravitreal injections for nAMD within 6 months before screening
- Shown a response to prior anti-VEGF treatment since diagnosis
- Available historical visual acuity data from diagnosis before first anti-VEGF treatment
- Available historical OCT image data from diagnosis before first anti-VEGF treatment
- Best corrected visual acuity of 34 letters or better using the ETDRS chart at 4 meters at screening and enrollment visits
You will not qualify if you...
- History of vitrectomy, submacular surgery, or other AMD eye surgery in the study eye
- Previous corticosteroid intravitreal injection in the study eye
- Previous intraocular device implantation in the study eye
- History of vitreous hemorrhage or rhegmatogenous retinal detachment in the study eye
- History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery in the study eye
- History of corneal transplant in the study eye
- Severe allergic or anaphylactic reactions to biologic agents or components of study treatments
- Prior participation in experimental nAMD therapy trials
- Prior treatment with brolucizumab or gene therapy for nAMD
- Subretinal hemorrhage involving the center of the fovea in the study eye
- Subfoveal fibrosis or subfoveal atrophy in the study eye
- CNV caused by other diseases like ocular histoplasmosis, trauma, or pathologic myopia
- Any concurrent intraocular condition needing surgery during the study or affecting results in the study eye
- Active intraocular inflammation or untreated retinal tears in the study eye
- Aphakia or absence of posterior capsule in the study eye
- Uncontrolled ocular hypertension or glaucoma in the study eye
- Severe eyelid or eye surface diseases
- Non-functioning or absent non-study eye
- Active or history of uveitis, keratitis, scleritis, endophthalmitis, or chronic blepharitis
- Suspected or active ocular/periocular infections
- Active thyroid eye disease
- Uncontrolled blood pressure
- Active or history of autoimmune diseases
- Recent stroke, atrial fibrillation, or myocardial infarction within 3 months before consent
- Confirmed active systemic infection
- Other diseases or conditions contraindicating ranibizumab or implant placement
- Use of systemic anti-VEGF agents
- Chronic oral corticosteroid use
- Active cancer within 12 months except certain treated cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Day 1 plus up to 37 days post-surgery
Participants undergo surgical insertion of the Port Delivery System (PDS) implant with ranibizumab in the study eye.
1 surgical visit and approximately 6 post-operative visits
Duration - Up to 72 weeks
Participants receive ranibizumab delivered via the PDS implant with refill-exchange schedules every 24 or 36 weeks depending on disease activity and supplemental treatment needs.
Visits scheduled according to refill-exchange every 24 or 36 weeks with additional visits for supplemental ranibizumab injections as needed
Duration - Up to approximately 19 months post initial implantation surgery
Participants are monitored for safety, visual acuity, and ocular health following treatment completion.
Follow-up visits beyond 37 days after implantation surgery up to 72 weeks
Trial Site Locations
Total: 57 locations
1
Medizinische Universität Innsbruck
Innsbruck, Austria, 6020
Actively Recruiting
2
Kepler Universitätskliniken GmbH - Med Campus III
Linz, Austria, 4021
Actively Recruiting
3
Landesklinikum Mistelbach
Mistelbach, Austria, 2130
Actively Recruiting
4
Klaudianova Nemocnice - Mlada Boleslav;Ophtalmology dpt
Mladá Boleslav, Czechia, 293 50
Actively Recruiting
5
Faculty Hospital Ostrava
Ostrava, Czechia, 708 52
Actively Recruiting
6
Aarhus Universitetshospital
Aarhus N, Denmark, 8200
Actively Recruiting
7
Rigshospitalet Glostrup
Glostrup Municipality, Denmark, 2600
Actively Recruiting
8
Institut Ophtalmologique De l Ouest Jules Verne
Nantes, Paris, France, 44300
Actively Recruiting
9
Hopital Edouard Herriot - CHU Lyon
Lyon, France, 69003
Actively Recruiting
10
Clinique Honore Cave
Montauban, France, 82000
Actively Recruiting
11
CHNO des Quinze Vingts
Paris, France, 75012
Actively Recruiting
12
CHU Poitiers - CHR La Miletrie
Poitiers, France, 86021
Actively Recruiting
13
CHU Strasbourg - Nouvel Hopital Civil
Strasbourg, France, 67091
Actively Recruiting
14
Klinikum Chemnitz gGmbH
Chemnitz, Germany, 09116
Actively Recruiting
15
Universitätkslinikum Düsseldorf, Augenklinik
Düsseldorf, Germany, 40225
Actively Recruiting
16
Universitätsmedizin Göttingen Georg-August-Universität
Göttingen, Germany, 37075
Actively Recruiting
17
Medizinische Hochschule Hannover, Klinik für Augenheilkunde
Hanover, Germany, 30625
Actively Recruiting
18
Universitätsmedizin Rostock
Rostock, Germany, 18057
Actively Recruiting
19
Universitätsklinikum Würzburg, Augenklinik und Poliklinik
Würzburg, Germany, 97080
Actively Recruiting
20
"G.Gennimatas" General Hospital of Athens
Athens, Attica, Greece, 115 27
Actively Recruiting
21
Attikon University General Hospital
Chaïdári, Greece, 124 62
Actively Recruiting
22
University General Hospital of Heraklion
Heraklon, Greece, 711 10
Actively Recruiting
23
University Hospital of Larissa
Larissa, Greece, 412 21
Actively Recruiting
24
Ospedale Monaldi - AORN dei Colli
Naples, Campania, Italy, 80131
Actively Recruiting
25
Azienda Ospedaliero - Universitaria di Ferrara - Arcispedale Sant'Anna, Sede Ospedale di Cona;UO di Clinica Oculistica
Cona (Ferrara), Emilia-Romagna, Italy, 44122
Actively Recruiting
26
Ospedale Isola Tiberina - Gemelli Isola;UOC Chirurgia Vitreoretinica
Rome, Lazio, Italy, 00186
Actively Recruiting
27
ASST SANTI PAOLO E CARLO - Presidio San Paolo;SC Oculistica
Milan, Lombardy, Italy, 20142
Actively Recruiting
28
Azienda Ospedaliero-Universitaria Ospedale Maggiore della Carità;S.C.D.U. Oftalmologia
Novara, Piedmont, Italy, 28100
Actively Recruiting
29
A.O.U. Policlinico Paolo Giaccone;Oculistica
Palermo, Sicily, Italy, 90142
Actively Recruiting
30
MW-med
Krakow, Lesser Poland Voivodeship, Poland, 31 416
Actively Recruiting
31
Szpital sw. Lukasza
Bielsko-Biala, Poland, 43-309
Actively Recruiting
32
Specjalistyczny O?rodek Okulistyczny Oculomedica
Bydgoszcz, Poland, 85-316
Actively Recruiting
33
OFTALMIKA Sp. z o.o
Bydgoszcz, Poland, 85-631
Actively Recruiting
34
Niepubliczny Zak?ad Opieki Zdrowotnej PRYZMAT-OKULISTYKA
Gliwice, Poland, 44-100
Actively Recruiting
35
Klinika Okulistyczna Jasne Błonia Sp. z o. o.
Lódz, Poland, 91-134
Actively Recruiting
36
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie;Klinika Chirurgii Siatkówki i Cia?a Szklistego
Lublin, Poland, 20-079
Actively Recruiting
37
Centrum Diagnostyki i Mikrochirurgii Oka LENS
Olsztyn, Poland, 10-424
Actively Recruiting
38
Kyungpook National University Hospital
Daegu, South Korea, 41944
Actively Recruiting
39
Ajou University Medical Center
Gyeonggi-do, South Korea, 16499
Actively Recruiting
40
Korea University Anam Hospital
Seoul, South Korea, 02841
Actively Recruiting
41
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
42
Seoul St Mary's Hospital
Seoul, South Korea, 06591
Actively Recruiting
43
Boramae Medical Center
Seoul, South Korea, 07061
Actively Recruiting
44
Hallym University Kangnam Sacred Heart Hospital
Seoul, South Korea, 07441
Actively Recruiting
45
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
46
Hospital Universitario Virgen del Rocio
Seville, Spain, 41013
Actively Recruiting
47
Hospital Arnau de Vilanova (Valencia)
Valencia, Spain, 46015
Actively Recruiting
48
Berner Augenklinik
Bern, Switzerland, 3007
Actively Recruiting
49
Pallas Klinik Olten
Olten, Switzerland, 4600
Actively Recruiting
50
Kantonsspital St. Gallen
Sankt Gallen, Switzerland, 9007
Actively Recruiting
51
King Chulalongkorn Memorial Hospital
Bangkok, Thailand, 10330
Actively Recruiting
52
Rajavithi Hospital
Bangkok, Thailand, 10400
Actively Recruiting
53
Maharaj Nakorn ChiangMai Hospital
Chiang Mai, Thailand, 50200
Actively Recruiting
54
Songklanagarind Hospital
Songkhla, Thailand, 90110
Actively Recruiting
55
Leicester Royal Infirmary
Leicester, Leicestershire, United Kingdom, LE1 5WW
Actively Recruiting
56
Gloucestershire Royal Hospital
Gloucester, United Kingdom, GL1 3NN
Actively Recruiting
57
Moorfields Eye Hospital NHS Foundation Trust
London, United Kingdom, EC1V 2PD
Actively Recruiting
Research Team
R
Reference Study ID Number: MR45625 https://forpatients.roche.com/
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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