Actively Recruiting
A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME
Led by Hoffmann-La Roche · Updated on 2026-03-06
634
Participants Needed
92
Research Sites
424 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate the efficacy, safety, and Pharmacokinetics (PK) of the PDS with ranibizumab in participants with DME when treated every 24 weeks (Q24W) compared with intravitreal (IVT) ranibizumab 0.5 milligrams (mg) every 4 weeks (Q4W). The substudy will evaluate safety of re-implanting the updated PDS with ranibizumab and the refill-exchange procedures following re-implantation in participants with DME who were previously enrolled in the main study, GR40550. Up to 100 participants from the main study will be enrolled and followed for a maximum of 72 weeks post-re-implantation in the substudy.
CONDITIONS
Official Title
A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of consent
- Diagnosed with diabetes mellitus (Type 1 or Type 2)
- Glycated haemoglobin (HbA1c) level of 10% or less within 2 months prior to screening or at screening
- Macular thickening due to diabetic macular edema involving the center of the fovea with central subfield thickness of 325 micrometers or more on SD-OCT at screening
- Best-corrected visual acuity score between 78 and 25 letters (approximately 20/32 to 20/320 Snellen equivalent)
- For substudy: experienced septum dislodgement in original implant during or after main study
- For substudy: sufficiently clear ocular media and adequate pupil dilation for central reading analysis
You will not qualify if you...
- High-risk proliferative diabetic retinopathy
- Active intraocular inflammation grade trace or above
- Suspected or active ocular or periocular infection in either eye
- Uncontrolled ocular hypertension or glaucoma that may require filtering surgery during the study
- Cerebrovascular accident or heart attack within 6 months before randomization
- Atrial fibrillation diagnosis or worsening within 6 months before randomization
- Uncontrolled blood pressure
- For substudy cohort 1: recent other disease or metabolic dysfunction, or clinical findings suggesting contraindication to ranibizumab or PDS implant surgery
- Active cancer within past 12 months (except treated carcinoma in situ of cervix, non-melanoma skin cancer, or prostate cancer)
- Current systemic treatment for confirmed active systemic infection
- Participation in investigational trial involving drug or device (except vitamins, minerals, or study GR40550) within 6 months prior to enrollment
- Use of antimitotic or antimetabolite therapy within 30 days
- Any ocular condition posing high risk for surgical or treatment complications
- Intraocular surgery within 1 month before enrollment visit
- Use of medicated intraocular implants other than PDS implant before enrollment
- History of retinal tears or peripheral retinal breaks within 3 months before enrollment
- Ocular condition requiring surgical intervention during study to prevent or treat vision loss
- Conjunctival, tenon's capsule, or scleral conditions in supero-temporal quadrant affecting refill-exchange procedure
- Ongoing ocular complications affecting participant safety
- History of uveitis
- Active blepharitis or suspected ocular/periocular infection such as infectious conjunctivitis or endophthalmitis in either eye
- For substudy: any condition contraindicating treatment or surgery as per investigator assessment within last 3 months before enrollment or other exclusion criteria as specified for cohort 1 only (see full criteria)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 92 locations
1
Barnet Dulaney Perkins Eye Center
Mesa, Arizona, United States, 85206
Completed
2
Retinal Consultants of Arizona;Opthalmology
Phoenix, Arizona, United States, 85014
Completed
3
Arizona Retina and Vitreous Consultants
Phoenix, Arizona, United States, 85016
Completed
4
Associated Retina Consultants
Phoenix, Arizona, United States, 85020
Completed
5
California Retina Consultants
Bakersfield, California, United States, 93309
Actively Recruiting
6
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
Completed
7
The Retina Partners
Encino, California, United States, 91436
Completed
8
Retina Consultants of Orange County;Clinical Research
Fullerton, California, United States, 92835
Actively Recruiting
9
Jules Stein Eye Institute/ UCLA
Los Angeles, California, United States, 90095
Completed
10
Northern California Retina-Vitreous Associates
Mountain View, California, United States, 94040
Completed
11
East Bay Retina Consultants
Oakland, California, United States, 94609
Actively Recruiting
12
Doheny Eye Institute
Pasadena, California, United States, 91105
Completed
13
California Eye Specialists Medical Group
Pasadena, California, United States, 91107
Completed
14
Retina Consultants Medical Group
Sacramento, California, United States, 95841
Actively Recruiting
15
Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, United States, 94110
Completed
16
Orange County Retina Medical Group
Santa Ana, California, United States, 92705
Actively Recruiting
17
California Retina Consultants;Research Department
Santa Barbara, California, United States, 93103
Completed
18
Eye Center of Northern Colorado
Fort Collins, Colorado, United States, 80528
Completed
19
Colorado Clinical Research
Lakewood, Colorado, United States, 80228
Completed
20
Retina Group of New England
Waterford, Connecticut, United States, 06385
Active, Not Recruiting
21
Retina Group of Florida
Fort Lauderdale, Florida, United States, 33308
Completed
22
National Ophthalmic Research Institute
Fort Myers, Florida, United States, 33912
Completed
23
Retina Specialty Institute
Pensacola, Florida, United States, 32503
Actively Recruiting
24
Fort Lauderdale Eye Institute
Plantation, Florida, United States, 33324
Actively Recruiting
25
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States, 33711
Actively Recruiting
26
Southern Vitreoretinal Associates;Research
Tallahassee, Florida, United States, 32308
Actively Recruiting
27
Retina Associates of Florida;Retina Associates of Florida
Tampa, Florida, United States, 33609
Completed
28
Southeast Retina Center
Augusta, Georgia, United States, 30909
Actively Recruiting
29
Georgia Retina
Marietta, Georgia, United States, 30060
Completed
30
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Completed
31
Illinois Retina Associates
Joliet, Illinois, United States, 60435
Completed
32
University Retina
Lemont, Illinois, United States, 60439
Completed
33
Wolfe Eye Clinic
West Des Moines, Iowa, United States, 50266
Completed
34
Retina Associates
Lenexa, Kansas, United States, 66215
Completed
35
Retina & Vitreous Associates of Kentucky
Lexington, Kentucky, United States, 40509
Completed
36
Maine Eye Center
Portland, Maine, United States, 04605
Active, Not Recruiting
37
The Retina Care Center
Baltimore, Maryland, United States, 21209
Withdrawn
38
Johns Hopkins Hospital;Johns Hopkins Med;Wilmer Eye Inst
Baltimore, Maryland, United States, 21287
Completed
39
The Retina Group of Washington;Retinal Disease
Chevy Chase, Maryland, United States, 20815
Actively Recruiting
40
Cumberland Valley Retina Consultants;Clinical Research
Hagerstown, Maryland, United States, 21740
Actively Recruiting
41
Retina Specialist
Towson, Maryland, United States, 21204
Completed
42
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Active, Not Recruiting
43
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
Completed
44
Vitreo Retinal Associates
Worcester, Massachusetts, United States, 01605
Completed
45
Retina Specialists Of Michigan
Grand Rapids, Michigan, United States, 49546
Completed
46
Associated Retinal Consultants - Royal Oak
Royal Oak, Michigan, United States, 48073
Completed
47
VitreoRetinal Surgery PLLC;DBA Retina Consultants of Minnesota
Minneapolis, Minnesota, United States, 55435
Completed
48
Pepose Vision Institute
Chesterfield, Missouri, United States, 63017
Completed
49
Retina Institute
St Louis, Missouri, United States, 63128
Completed
50
Sierra Eye Associates
Reno, Nevada, United States, 89502
Actively Recruiting
51
Envision Ocular, LLC
Bloomfield, New Jersey, United States, 07003
Completed
52
Retina Associates of New Jersey
Teaneck, New Jersey, United States, 07666
Active, Not Recruiting
53
Long Island Vitreoretinal Consultants;Opthalmology
Great Neck, New York, United States, 11021
Completed
54
Retina Vitreous Surgeons of Central New York
Liverpool, New York, United States, 13088
Actively Recruiting
55
New York University (NYU)
New York, New York, United States, 10012
Completed
56
Ophthalmic Consultants of Long Island
Oceanside, New York, United States, 11572
Completed
57
Asheville Eye Associates Western Carolina Retinal Associates;Clinical Research
Asheville, North Carolina, United States, 28803
Completed
58
Charlotte Eye Ear Nose and Throat Associates- SouthPark;Retina
Charlotte, North Carolina, United States, 28210
Completed
59
Duke Eye Center
Durham, North Carolina, United States, 27705
Completed
60
Graystone Eye;Clinical Research
Hickory, North Carolina, United States, 28602
Completed
61
Cape Fear Retinal Associates
Wilmington, North Carolina, United States, 28401
Withdrawn
62
Cincinnati Eye Institute;Retina
Cincinnati, Ohio, United States, 45242
Actively Recruiting
63
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Completed
64
Ohio State Havener Eye Institute;Ophthalmology Research
Columbus, Ohio, United States, 43212
Actively Recruiting
65
Midwest Retina;Retina/Vitreous
Dublin, Ohio, United States, 43016
Completed
66
Retina Vitreous Center - Glen Eagles
Edmond, Oklahoma, United States, 73013
Completed
67
Retina Northwest;Research Department
Portland, Oregon, United States, 97221
Completed
68
Cumberland Valley Retina Consultants
Chambersburg, Pennsylvania, United States, 17201
Withdrawn
69
Mid Atlantic Retina
Philadelphia, Pennsylvania, United States, 19107
Completed
70
Charleston Neuroscience
Ladson, South Carolina, United States, 29456
Completed
71
Carolina Eyecare Physicians
Mt. Pleasant, South Carolina, United States, 29464
Completed
72
Palmetto Retina Center
West Columbia, South Carolina, United States, 29169
Completed
73
Palmetto Retina Center
West Columbia, South Carolina, United States, 29169
Withdrawn
74
Charles Retina Institution;Retina surgery
Germantown, Tennessee, United States, 38138
Actively Recruiting
75
Tennessee Retina
Nashville, Tennessee, United States, 37203
Active, Not Recruiting
76
Retina Research Institute of Texas
Abilene, Texas, United States, 79606
Completed
77
Texas Retina Associates
Arlington, Texas, United States, 76012
Completed
78
Austin Research Center for Retina
Austin, Texas, United States, 78705
Completed
79
Austin Retina Associates;Opthalmology
Austin, Texas, United States, 78705
Completed
80
Austin Clinical Research, LLC
Austin, Texas, United States, 78750
Completed
81
Retina & Vitreous of Texas
Bellaire, Texas, United States, 77401
Actively Recruiting
82
Texas Retina Associates;Research
Dallas, Texas, United States, 75231
Completed
83
Texas Retina Associates
Fort Worth, Texas, United States, 76104
Completed
84
Retina Consultants of Texas
Houston, Texas, United States, 77401
Actively Recruiting
85
Medical Center Ophthalmology Associates
San Antonio, Texas, United States, 78240
Actively Recruiting
86
Rocky Mountain Retina Consultants
Murray, Utah, United States, 84107
Completed
87
Retina Associates of Utah, PLLC;Clinical Research
Salt Lake City, Utah, United States, 84107
Completed
88
Piedmont Eye Center
Lynchburg, Virginia, United States, 24502
Completed
89
Wagner Kapoor Institute;Opthalmology
Norfolk, Virginia, United States, 23502
Completed
90
Retina Institute of Virginia
Richmond, Virginia, United States, 23235
Completed
91
Pacific Northwest Retina
Silverdale, Washington, United States, 98383
Completed
92
Spokane Eye Clinical Research;Spokane Eye Surgery Center
Spokane, Washington, United States, 99204
Actively Recruiting
Research Team
R
Reference Study ID Number: GR40550 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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