CompletedNCT01945866Updated Sep 25, 2018Results posted

Phase II Combination Steroid and Anti-VEGF for Persistent DME

A Phase 2 interventional study of intravitreal ranibizumab 0.3 mg and dexamethasone intravitreal implant in Diabetic Macular Edema, sponsored by Jaeb Center for Health Research. Completed at 56 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-25.

Sponsored by Jaeb Center for Health Research · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 129
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

Although anti-vascular endothelial growth factor (VEGF) therapy is generally effective as treatment for center-involved diabetic macular edema (DME), a substantial proportion of anti-VEGF-treated eyes with DME do not achieve vision of 20/20 or complete resolution of retinal thickening. Indeed, over 50% of ranibizumab-treated eyes did not achieve a 2 or more line improvement in visual acuity from baseline at 2 years in Protocol I, a previous DRCR.net (Diabetic Retinopathy Clinical Research Network) study. Furthermore, 27% of ranibizumab-treated eyes still had central subfield (CSF) thickness on time-domain optical coherence tomography (OCT) ≥ 300 at 1 year, and more than 40% of ranibizumab-treated eyes did not achieve complete resolution of retinal thickening (\< 250 microns) by 2 years. Thus, there is a need for alternative or additional treatments that will improve vision by reducing retinal edema in eyes with persistent DME following previous anti-VEGF therapy. Intravitreal steroid is not as efficacious as ranibizumab in eyes with DME overall, but it has been shown to have a positive effect for DME in some eyes and might add benefit in eyes that are already receiving anti-VEGF.

The main objective of this study is to assess the short-term effects of combination steroid+anti-VEGF therapy on visual acuity and retinal thickness on OCT in comparison with that of continued anti-VEGF therapy alone in eyes with persistent central-involved DME and visual acuity impairment despite previous anti-VEGF treatment. This study will provide important information for the design of a future confirmatory phase III clinical trial on the efficacy of combination steroid and anti-VEGF in eyes with persistent DME and vision impairment following previous anti-VEGF therapy. The primary outcome for efficacy will be the mean change in visual acuity at 24 weeks.

Each study eye is required to complete a 12-week run-in phase. The run-in phase will identify study eyes that truly have persistent DME despite anti-VEGF therapy by requiring an additional 3 injections while also collecting standardized visual acuity and OCT measurements. At the enrollment, 4-week and 8-week visits of the run-in phase, enrolled eyes will receive an intravitreal injection of ranibizumab 3mg. Then at the 12-week run-in visit, if the eye still has persistent DME, it will be randomized to receive either intravitreal sham+intravitreal ranibizumab 0.3 or intravitreal dexamethasone+intravitreal ranibizumab 0.3 injections. The randomized study duration is 24 week, during which a protocol visit takes place every month. The combination injections of sham+ranibizumab or dexamethasone +ranibizumab will be given at the randomization visit (baseline) and at the 12-week visit after randomization. In between, an intravitreal injection of ranibizumab only will be given to study eyes at the 4, 8, 16 and 20 week visits.

Conditions studied

Diabetic Macular Edema

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Keywords

Diabetic Macular Edema
Anti-vascular endothelial growth factor
Dexamethasone Intravitreal implant
Ranibizumab intravitreal injection

In context

Macular Edema

841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.

This study's enrollment of 129 is above the median of 50 across 619 interventional studies indexed under Macular Edema.

Browse Macular Edema studies →

Lead sponsor

Jaeb Center for Health Research is the lead sponsor of 126 studies on the registry; 17 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 14 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Age ≥ 18 years i) Individuals \<18 years old are not being included because DME is so rare in this age group that the diagnosis of DME may be questionable.
Diagnosis of diabetes mellitus (type 1 or type 2)
Any one of the following will be considered to be sufficient evidence that diabetes is present:
1. Current regular use of insulin for the treatment of diabetes
2. Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
3. Documented diabetes by ADA (American Diabetes Association) and/or WHO (World Health Organization) criteria
At least one eye meets the study eye criteria listed below.
Fellow eye (if not a study eye) meets criteria.
Able and willing to provide informed consent.

Meets all of the following ocular criteria in at least the one eye:

At least 3 injections of anti-VEGF drug (ranibizumab, bevacizumab, or aflibercept) within the prior 20 weeks.
Visual acuity letter score in study eye ≤ 78 and ≥24 (approximate Snellen equivalent 20/32 to 20/320).
On clinical exam, definite retinal thickening due to DME involving the center of the macula.
OCT CSF thickness, within 8 days of enrollment:
i) On Zeiss Cirrus ≥ 290 microns in women; ≥ 305 in men ii) On Heidelberg Spectralis: ≥ 305 microns in women; ≥ 320 in men
Media clarity, pupillary dilation, and individual cooperation sufficient for adequate OCTs.

Exclusion criteria

Exclusion Criteria:

An individual is not eligible if any of the following exclusion criteria are present:

History of chronic renal failure requiring dialysis or kidney transplant.
A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
Initiation of intensive insulin treatment (a pump or multiple daily injections) within 4 months prior to randomization or plans to do so in the next 4 months.
Participation in an investigational trial within 30 days of enrollment that involved treatment with any drug that has not received regulatory approval for the indication being studied. Note: study participants cannot receive another investigational drug while participating in the study.
Known allergy to any component of the study drugs (including povidone iodine prep).
Blood pressure > 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, the individual can become eligible.
Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 1 month prior to enrollment.
Systemic steroid, anti-VEGF or pro-VEGF treatment within 4 months prior to enrollment or anticipated use during the study. These drugs cannot be used during the study.
For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 9 months. Women who are potential study participants should be questioned about the potential for pregnancy. Investigator judgment is used to determine when a pregnancy test is needed.
Individual is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the next 9 months.

The following exclusions apply to the study eye only (i.e., they may be present for the non-study eye unless otherwise specified):

Macular edema is considered to be due to a cause other than DME. An eye should not be considered eligible if: (1) the macular edema is considered to be related to ocular surgery such as cataract extraction or (2) clinical exam and/or OCT suggest that vitreoretinal interface abnormalities (e.g., a taut posterior hyaloid or epiretinal membrane) are the primary cause of the macular edema.
An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, non-retinal condition, etc.).
An ocular condition is present (other than DME) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.).
Substantial posterior capsule opacity that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., opacity would be reducing acuity to 20/40 or worse if eye was otherwise normal).
History of intravitreal anti-VEGF drug within 21 days prior to enrollment.
History of intravitreal or peribulbar corticosteroids within 3 months prior to enrollment.
History of macular laser photocoagulation within 4 months prior to enrollment.
History of panretinal (scatter) photocoagulation (PRP) within 4 months prior to enrollment or anticipated need for PRP in the 6 months following enrollment into run-in phase.
Any history of vitrectomy.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 129 participants (actual)

Study arms

Active comparator
Sham + intravitreal ranibizumab 0.3 mg
Intravitreal ranibizumab will be given on the day of randomization. The sham injection will be given within 0-8 days of the ranibizumab injection. If the injections are given consecutively on the same day, the sham injection must be given first. Follow-up intravitreal injections of ranibizumab will be given up to every 4 weeks using defined treatment criteria.
Drug: intravitreal ranibizumab 0.3 mg · Procedure: Sham injection
Experimental
Intravitreal dexamethasone+intravitreal ranibizumab 0.3mg
The initial intravitreal ranibizumab injection will be given on the day of randomization. The dexamethasone intravitreal injection will be given within 0-8 days of the ranibizumab injection. If defined criteria are met, a second dexamethasone injection in combination with intravitreal ranibizumab (within 0-8 days) will be given at the 12 week visit. If the injections are given consecutively on the same day, the ranibizumab injection must be given first.
Drug: intravitreal ranibizumab 0.3 mg · Drug: dexamethasone intravitreal implant

Interventions

Drugintravitreal ranibizumab 0.3 mg
Intravitreal injection of 0.3mg ranibizumab performed on the day of randomization and up to every 4 weeks using defined treatment criteria
Also known as: Lucentis
Drugdexamethasone intravitreal implant
The dexamethasone intravitreal injection will be given within 0-8 days of the ranibizumab injection. If defined criteria are met, a second dexamethasone injection in combination with intravitreal ranibizumab (within 0-8 days) will be given at the 12 week visit. If the injections are given consecutively on the same day, the ranibizumab injection must be given first.
Also known as: Ozurdex
ProcedureSham injection
No injection is given. It is a sham injection to keep the participant masked. The sham injection will be given within 0-8 days of the ranibizumab injection. If the injections are given consecutively on the same day, the sham injection must be given first.

What researchers measure

Primary outcomes

Mean Change in Visual Acuity Letter Score
At 24 weeks after randomization, mean change in visual acuity letter score, adjusted for visual acuity at time of randomization
Time frame: 24 weeks after randomization

Secondary outcomes

At 24 Weeks After Randomization, Number of Eyes With at Least 10 and at Least 15 Letter Gain (Increase) or Loss (Decrease) in E-ETDRS Letter Score Visual Acuity.
ETDRS (Early Treatment Diabetic Retinopathy Study)
Time frame: 24 weeks weeks after randomization
Visual Acuity Area Under the Curve (AUC) Between Randomization and 24 Weeks
Only included participants who completed the 24-week visit. Time points for which data were collected for this analysis include 0, 4 8,12, 16, 20, and 24 weeks post randomization.
Time frame: 24 weeks after randomization
Mean Change in OCT CSF Thickness, Adjusted for Thickness at Time of Randomization
Change in optical coherence tomography (OCT) central subfield thickness (in microns) was truncated to 3 standard deviations from the mean \[-372, +201\] (calculated using observed changes at 24 weeks combining all treatment groups), to minimize the effect of outliers. Two values were truncated in the sham + ranibizumab group: one on the negative end, and one on the positive end.
Time frame: 24 weeks after randomization
Number of Eyes With ≥1 and ≥2 logOCT Step Gain or Loss in CSF Thickness
Change in optical coherence tomography (OCT) central subfield (CSF) thickness (in microns) was truncated to 3 standard deviations from the mean \[-372, +201\] (calculated using observed changes at 24 weeks combining all treatment groups), to minimize the effect of outliers. Two values were truncated in the sham + ranibizumab group: one on the negative end, and one on the positive end.
Time frame: 24 weeks after randomization
Eyes With OCT CSF Thickness < the Gender-specific Spectral Domain OCT Equivalent of 250 Microns on Zeiss Stratus
Gender and OCT machine-specific values for OCT central subfield thickness (in microns) are defined as: \<290 in women and \<305 in men in Zeiss Cirrus; \<305 in women and \<320 in men in Heidelberg Spectralis
Time frame: 24 weeks after randomization
OCT CSF Thickness Area Under the Curve Between Randomization and 24 Weeks
Including participants who completed the 24-week visit. Time points for which data were collected for this analysis include 0, 4 8,12, 16, 20, and 24 weeks post randomization.
Time frame: 24 weeks after randomization

Results

Posted Sep 25, 2018

Participant flow

Phase 2 multi center randomized trial conducted at 40 US sites; 129 eyes (116 adults) with diabetes between February 2014 and December 2016. Participants with 2 study eyes enrolled one eye in each arm. Therefore, each arm includes no more than 1 study eye per participant; thus the number of eyes is equal to the number of participants in each arm.

Participant flow — Overall Study
Milestone	Sham + Intravitreal Ranibizumab 0.3 mg	Intravitreal Dexamethasone+Intravitreal Ranibizumab 0.3mg
Started	65	64
Completed	63	64
Not completed	2	0
Withdrew: Eyes did not complete or were dropped	2	0

Outcome measures

PrimaryMean Change in Visual Acuity Letter Score

At 24 weeks after randomization, mean change in visual acuity letter score, adjusted for visual acuity at time of randomization

Time frame:: 24 weeks after randomization
Reported as:: Mean · Letter Score

Mean Change in Visual Acuity Letter Score
Letter Score	Intravitreal Dexamethasone+Intravitreal Ranibizumab 0.3mg	Sham + Intravitreal Ranibizumab 0.3 mg
Mean Change in Visual Acuity Letter Score	2.7 ± 9.8	3.0 ± 7.1

SecondaryAt 24 Weeks After Randomization, Number of Eyes With at Least 10 and at Least 15 Letter Gain (Increase) or Loss (Decrease) in E-ETDRS Letter Score Visual Acuity.

ETDRS (Early Treatment Diabetic Retinopathy Study)

Time frame:: 24 weeks weeks after randomization
Reported as:: Number · Eyes

At 24 Weeks After Randomization, Number of Eyes With at Least 10 and at Least 15 Letter Gain (Increase) or Loss (Decrease) in E-ETDRS Letter Score Visual Acuity.
Eyes	Intravitreal Dexamethasone+Intravitreal Ranibizumab 0.3mg	Sham + Intravitreal Ranibizumab 0.3 mg
>= 15 Letter Improvement	7	1
>= 10 Letter Improvement	14	9
>= 10 Letter Worsening	8	4
>= 15 Letter Worsening	4	3

SecondaryVisual Acuity Area Under the Curve (AUC) Between Randomization and 24 Weeks

Only included participants who completed the 24-week visit. Time points for which data were collected for this analysis include 0, 4 8,12, 16, 20, and 24 weeks post randomization.

Time frame:: 24 weeks after randomization
Reported as:: Mean · Letter Score

Visual Acuity Area Under the Curve (AUC) Between Randomization and 24 Weeks
Letter Score	Intravitreal Dexamethasone+Intravitreal Ranibizumab 0.3mg	Sham + Intravitreal Ranibizumab 0.3 mg
Visual Acuity Area Under the Curve (AUC) Between Randomization and 24 Weeks	1.9 ± 6.3	2.5 ± 4.4

SecondaryMean Change in OCT CSF Thickness, Adjusted for Thickness at Time of Randomization

Change in optical coherence tomography (OCT) central subfield thickness (in microns) was truncated to 3 standard deviations from the mean \[-372, +201\] (calculated using observed changes at 24 weeks combining all treatment groups), to minimize the effect of outliers. Two values were truncated in the sham + ranibizumab group: one on the negative end, and one on the positive end.

Time frame:: 24 weeks after randomization
Reported as:: Mean · microns

Mean Change in OCT CSF Thickness, Adjusted for Thickness at Time of Randomization
microns	Intravitreal Dexamethasone+Intravitreal Ranibizumab 0.3mg	Sham + Intravitreal Ranibizumab 0.3 mg
Mean Change in OCT CSF Thickness, Adjusted for Thickness at Time of Randomization	-110 ± 86	-62 ± 97

SecondaryNumber of Eyes With ≥1 and ≥2 logOCT Step Gain or Loss in CSF Thickness

Change in optical coherence tomography (OCT) central subfield (CSF) thickness (in microns) was truncated to 3 standard deviations from the mean \[-372, +201\] (calculated using observed changes at 24 weeks combining all treatment groups), to minimize the effect of outliers. Two values were truncated in the sham + ranibizumab group: one on the negative end, and one on the positive end.

Time frame:: 24 weeks after randomization
Reported as:: Number · Eyes

Number of Eyes With ≥1 and ≥2 logOCT Step Gain or Loss in CSF Thickness
Eyes	Intravitreal Dexamethasone+Intravitreal Ranibizumab 0.3mg	Sham + Intravitreal Ranibizumab 0.3 mg
>=1 LogOCT step improvement	34	22
>= 2 LogOCT step improvement	14	8
>=1 LogOCT step worsening	0	1
>=2 LogOCT step worsening	0	1

SecondaryEyes With OCT CSF Thickness < the Gender-specific Spectral Domain OCT Equivalent of 250 Microns on Zeiss Stratus

Gender and OCT machine-specific values for OCT central subfield thickness (in microns) are defined as: \<290 in women and \<305 in men in Zeiss Cirrus; \<305 in women and \<320 in men in Heidelberg Spectralis

Time frame:: 24 weeks after randomization
Reported as:: Number · Eyes

Eyes With OCT CSF Thickness < the Gender-specific Spectral Domain OCT Equivalent of 250 Microns on Zeiss Stratus
Eyes	Intravitreal Dexamethasone+Intravitreal Ranibizumab 0.3mg	Sham + Intravitreal Ranibizumab 0.3 mg
Eyes With OCT CSF Thickness < the Gender-specific Spectral Domain OCT Equivalent of 250 Microns on Zeiss Stratus	32	20

SecondaryOCT CSF Thickness Area Under the Curve Between Randomization and 24 Weeks

Including participants who completed the 24-week visit. Time points for which data were collected for this analysis include 0, 4 8,12, 16, 20, and 24 weeks post randomization.

Time frame:: 24 weeks after randomization
Reported as:: Mean · microns

OCT CSF Thickness Area Under the Curve Between Randomization and 24 Weeks
microns	Intravitreal Dexamethasone+Intravitreal Ranibizumab 0.3mg	Sham + Intravitreal Ranibizumab 0.3 mg
OCT CSF Thickness Area Under the Curve Between Randomization and 24 Weeks	-86.9 ± 65.6	-33.5 ± 56.8

Adverse events

Collected over From Randomization to 24-weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Intravitreal Dexamethasone+Intravitreal Ranibizumab 0.3mg	0/52 (0%)	7/52 (13.5%)	38/52 (73.1%)
Sham + Intravitreal Ranibizumab 0.3 mg	0/51 (0%)	7/51 (13.7%)	29/52 (55.8%)
Bilateral	0/13 (0%)	1/13 (7.7%)	11/13 (84.6%)

Most frequent serious events

Showing 10 of 14

Most frequent serious events
Event	Intravitreal Dexamethasone+Intravitreal Ranibizumab 0.3mg	Sham + Intravitreal Ranibizumab 0.3 mg	Bilateral
Multiple fracturesMusculoskeletal and connective tissue disorders	1/52	0/51	1/13
HypoglycaemiaEndocrine disorders	0/52	1/51	0/13
InfectionInfections and infestations	0/52	1/51	0/13
Acute kidney injuryRenal and urinary disorders	1/52	1/51	0/13
PneumoniaRespiratory, thoracic and mediastinal disorders	0/52	1/51	0/13
Stent placementSurgical and medical procedures	0/52	1/51	0/13
Vascular graftSurgical and medical procedures	0/52	1/51	0/13
Cerebrovascular accidentVascular disorders	0/52	1/51	0/13
HypertensionVascular disorders	0/52	1/51	0/13
Diastolic dysfunctionCardiac disorders	1/52	0/51	0/13

Most frequent other events

Showing 10 of 100

Most frequent other events
Event	Intravitreal Dexamethasone+Intravitreal Ranibizumab 0.3mg	Sham + Intravitreal Ranibizumab 0.3 mg	Bilateral
Intraocular pressure increasedInvestigations	11/52	0/51	3/13
Cataract nuclearEye disorders	1/52	0/51	2/13
Cataract subcapsularEye disorders	1/52	0/51	2/13
Vitreous floatersEye disorders	8/52	3/51	1/13
CoughRespiratory, thoracic and mediastinal disorders	0/52	0/51	2/13
Vision blurredEye disorders	7/52	4/51	0/13
HypoglycaemiaEndocrine disorders	0/52	0/51	1/13
Cataract corticalEye disorders	0/52	0/51	1/13
Conjunctival haemorrhageEye disorders	4/52	0/51	1/13
Corneal defectEye disorders	0/52	0/51	1/13

Baseline characteristics

Units in Eyes

Age, Customized
Age, Customized(years)	Sham + Intravitreal Ranibizumab 0.3 mg	Intravitreal Dexamethasone+Intravitreal Ranibizumab 0.3mg	Total
Age	66 (59 to 71)	64 (59 to 69)	65 (59 to 70)

Sex/Gender, Customized
Sex/Gender, Customized(Eyes)	Sham + Intravitreal Ranibizumab 0.3 mg	Intravitreal Dexamethasone+Intravitreal Ranibizumab 0.3mg	Total
Women	36	31	67
Male	28	34	62

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Eyes)	Sham + Intravitreal Ranibizumab 0.3 mg	Intravitreal Dexamethasone+Intravitreal Ranibizumab 0.3mg	Total
White	35	39	74
Black/African American	9	6	15
Hispanic or Latino	16	13	29
Asian	2	6	8
Native Hawaiian or other Pacific Islander	1	0	1
Unknown/not reported	1	1	2

Diabetes Type
Diabetes Type(Eyes)	Sham + Intravitreal Ranibizumab 0.3 mg	Intravitreal Dexamethasone+Intravitreal Ranibizumab 0.3mg	Total
Type 1	2	2	4
Type 2	61	62	123
Uncertain	1	1	2

Duration of Diabetes
Duration of Diabetes(years)	Sham + Intravitreal Ranibizumab 0.3 mg	Intravitreal Dexamethasone+Intravitreal Ranibizumab 0.3mg	Total
Median	19 (10 to 26)	15 (10 to 21)	17 (10 to 24)

Insulin Used
Insulin Used(Participants)	Sham + Intravitreal Ranibizumab 0.3 mg	Intravitreal Dexamethasone+Intravitreal Ranibizumab 0.3mg	Total
Count of participants	39	40	79

Hemoglobin A1c
Hemoglobin A1c(Percent Hemoglobin)	Sham + Intravitreal Ranibizumab 0.3 mg	Intravitreal Dexamethasone+Intravitreal Ranibizumab 0.3mg	Total
Median	7.4 (6.6 to 8.2)	7.1 (6.4 to 8.3)	7.3 (6.5 to 8.2)

Arterial Blood Pressure
Arterial Blood Pressure(mmHg)	Sham + Intravitreal Ranibizumab 0.3 mg	Intravitreal Dexamethasone+Intravitreal Ranibizumab 0.3mg	Total
Median	98 (87 to 106)	97 (87 to 106)	97 (87 to 106)

13 further baseline measures are reported on the registry.

Study locations

56 sites

Retina-Vitreous Associates Medical Group
Beverly Hills, California 90211, United States
Atlantis Eye Care
Huntington Beach, California 92647, United States
Loma Linda University Health Care, Dept. of Ophthalmology
Loma Linda, California 92354, United States
Northern California Retina Vitreous Associates
Mountain View, California 94040, United States
Retina Consultants of Southern California
Redlands, California 92374, United States
Retinal Consultants Medical Group, Inc.
Sacramento, California 95841, United States
California Retina Consultants
Santa Barbara, California 93103, United States
Bay Area Retina Associates
Walnut Creek, California 94598, United States
Retina Group of New England
New London, Connecticut 06320, United States
New England Retina Associates
Norwich, Connecticut 06360, United States
National Ophthalmic Research Institute
Fort Myers, Florida 33912, United States
University of Florida College of Med., Department of Ophthalmology
Jacksonville, Florida 32209, United States
Central Florida Retina Institute
Lakeland, Florida 33805, United States
Ocala Eye Retina Consultants
Ocala, Florida 34474, United States
Sarasota Retina Institute
Sarasota, Florida 34239, United States
Retina Associates of Florida, P.A.
Tampa, Florida 33609, United States
Southeast Retina Center, P.C.
Augusta, Georgia 30909, United States
Thomas Eye Group
Sandy Springs, Georgia 30328, United States
Raj K. Maturi, M.D., P.C.
Indianapolis, Indiana 46290, United States
Medical Associates Clinic, P.C.
Dubuque, Iowa 52002, United States
Wolfe Eye Clinic
West Des Moines, Iowa 50266, United States
Retina Associates, P.A.
Shawnee Mission, Kansas 66204, United States
Elman Retina Group, P.A.
Baltimore, Maryland 21237, United States
National Eye Institute/National Institutes of Health
Bethesda, Maryland 20892-2510, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts 02114, United States
Joslin Diabetes Center
Boston, Massachusetts 02215, United States
Retina Vitreous Center
Grand Blanc, Michigan 48439, United States
Retina Specialists of Michigan
Grand Rapids, Michigan 49525, United States
Retina Center, PA
Minneapolis, Minnesota 55404, United States
The Retina Institute
Saint Louis, Missouri 63128, United States
The Institute of Ophthalmology and Visual Science (IOVS)
Newark, New Jersey 07103, United States
MaculaCare
New York, New York 10021, United States
Retina Associates of Western New York
Rochester, New York 14618, United States
University of Rochester
Rochester, New York 14642, United States
Charlotte Eye Ear Nose and Throat Assoc, PA
Charlotte, North Carolina 28210, United States
Retina Associates of Cleveland, Inc.
Beachwood, Ohio 44122, United States
Case Western Reserve University
Cleveland, Ohio 44106, United States
Retina Northwest, PC
Portland, Oregon 97210, United States
Casey Eye Institute
Portland, Oregon 97239, United States
University of Pennsylvania Scheie Eye Institute
Philadelphia, Pennsylvania 19104, United States
Southeastern Retina Associates, P.C.
Knoxville, Tennessee 37909, United States
Southwest Retina Specialists
Amarillo, Texas 79106, United States
Austin Retina Associates
Austin, Texas 78705, United States
Retina Research Center
Austin, Texas 78705, United States
Retina and Vitreous of Texas
Houston, Texas 77025, United States
Baylor Eye Physicians and Surgeons
Houston, Texas 77030, United States
Retina Consultants of Houston, PA
Houston, Texas 77030, United States
Texas Retina Associates
Lubbock, Texas 79424, United States
Valley Retina Institute
McAllen, Texas 78503, United States
Retinal Consultants of San Antonio
San Antonio, Texas 78240, United States
Retina Associates of Utah, P.C.
Salt Lake City, Utah 84107, United States
Virginia Retina Center
Leesburg, Virginia 20176, United States
Retina Institute of Virginia
Richmond, Virginia 23235, United States
University of Washington Medical Center
Seattle, Washington 98195, United States
Spokane Eye Clinic
Spokane, Washington 99204, United States
University of Wisconsin-Madison, Dept of Ophthalmology/Retina Service
Madison, Wisconsin 53705, United States

References and documents

Publications

Maturi RK, Glassman AR, Liu D, Beck RW, Bhavsar AR, Bressler NM, Jampol LM, Melia M, Punjabi OS, Salehi-Had H, Sun JK; Diabetic Retinopathy Clinical Research Network. Effect of Adding Dexamethasone to Continued Ranibizumab Treatment in Patients With Persistent Diabetic Macular Edema: A DRCR Network Phase 2 Randomized Clinical Trial. JAMA Ophthalmol. 2018 Jan 1;136(1):29-38. doi: 10.1001/jamaophthalmol.2017.4914. PubMed 29127949 ↗

Study documents

Statistical analysis plan · Sep 25, 2017
Study protocol · Nov 16, 2015

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 25, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01945866
Lead sponsor: Jaeb Center for Health Research
Collaborators: Allergan, Genentech, Inc., National Eye Institute (NEI)
Responsible party: Sponsor
First posted: Sep 19, 2013
Start date: Feb 2014
Primary completion: Jun 5, 2017
Completion: Jun 5, 2017
Results posted: Sep 25, 2018
Last update: Sep 25, 2018

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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