Actively Recruiting
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Led by Hoffmann-La Roche · Updated on 2026-04-27
250
Participants Needed
56
Research Sites
150 weeks
Total Duration
On this page
Sponsors
H
Hoffmann-La Roche
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate 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.
CONDITIONS
Official 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...
- Initial diagnosis of nAMD within 24 months prior to screening
- Previous treatment with at least 3 anti-vascular endothelial growth factor (VEGF) intravitreal injections for nAMD within 6 months prior to screening
- Demonstrated response to prior anti-VEGF intravitreal treatment since diagnosis
- Availability of historical visual acuity data after nAMD diagnosis and before first anti-VEGF treatment
- Availability of historical OCT image data after nAMD diagnosis and before first anti-VEGF treatment
- Best corrected visual acuity of 34 letters or better using ETDRS chart at 4 meters at screening and enrollment visits
You will not qualify if you...
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
- Previous corticosteroid intravitreal injection in the study eye
- Previous intraocular device implantation in the study eye
- History of vitreous hemorrhage in the study eye
- History of 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
- History of severe allergic or anaphylactic reaction to biologic agents or any component of ranibizumab injections or related study preparations in either eye
- Prior participation in clinical trials with experimental therapies for nAMD
- 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 due to other causes such as ocular histoplasmosis, trauma, central serous chorioretinopathy, or pathologic myopia in either eye
- CNV masquerading lesions in either eye
- Subfoveal and/or juxtafoveal retinal pigment epithelial tear in the study eye
- Concurrent intraocular conditions requiring surgery during the study or affecting study results in the study eye
- Active intraocular inflammation in the study eye
- Untreated or recently treated retinal tears or peripheral retinal breaks in the study eye
- Aphakia or absence of the posterior capsule in the study eye
- Uncontrolled ocular hypertension or glaucoma in the study eye
- Severe posterior blepharitis, recurrent chalazia or hordeolum, severe dry eye syndrome, or severe allergic conjunctivitis in the study eye
- Trichiasis in the study eye
- Corneal neuropathy in the study eye
- Lagophthalmos or incomplete blink in the study eye
- Active or history of facial nerve palsy/paresis in the study eye
- Non-functioning non-study eye defined as BCVA of hand motion or worse or no physical presence of non-study eye
- Active or history of uveitis in either eye
- Active or history of keratitis, scleritis, endophthalmitis, or chronic blepharitis in either eye
- Suspected or active ocular or periocular infectious conjunctivitis or endophthalmitis in either eye
- Active or history of floppy eyelid syndrome in either eye
- Active thyroid eye disease in either eye
- Uncontrolled blood pressure
- Active or history of autoimmune diseases
- Stroke within 3 months prior to consent
- Atrial fibrillation diagnosed or worsened within 3 months prior to consent
- Myocardial infarction within 3 months prior to consent
- Confirmed active systemic infection
- Other diseases or lab findings 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
Trial Site Locations
Total: 56 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
Leicester Royal Infirmary
Leicester, Leicestershire, United Kingdom, LE1 5WW
Actively Recruiting
55
Gloucestershire Royal Hospital
Gloucester, United Kingdom, GL1 3NN
Actively Recruiting
56
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/
CONTACT
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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