CompletedNCT01489189Protocol SUpdated Oct 29, 2021Results posted

Prompt Panretinal Photocoagulation Versus Ranibizumab+Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy

A Phase 3 interventional study of Prompt Panretinal Photocoagulation and 0.5-mg Ranibizumab in Proliferative Diabetic Retinopathy, sponsored by Jaeb Center for Health Research. Completed at 48 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-29.

Sponsored by Jaeb Center for Health Research · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 305
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The primary objective of the protocol is to determine if visual acuity outcomes at 2 years in eyes with proliferative diabetic retinopathy (PDR) that receive anti-vascular endothelial growth factor (anti-VEGF) therapy with deferred panretinal photocoagulation (PRP) are non-inferior to those in eyes that receive standard prompt PRP therapy.

Secondary objectives include:

Comparing other visual function outcomes (including Humphrey visual field testing and study participant self-reports of visual function) in eyes receiving anti-VEGF with deferred PRP with those in eyes receiving prompt PRP.
Determining percent of eyes not requiring PRP when anti-VEGF is given in the absence of prompt PRP.
Comparing safety outcomes between treatment groups.
Comparing associated treatment and follow-up exam costs between treatment groups.

Conditions studied

Proliferative Diabetic Retinopathy

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In context

Retinal Diseases

815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.

This study's enrollment of 305 is above the median of 60 across 500 interventional studies indexed under Retinal Diseases.

Browse Retinal Diseases 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 -Individuals \< 18 years old are not being included because proliferative diabetic retinopathy (PDR) is so rare in this age group that the diagnosis of PDR 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:

Current regular use of insulin for the treatment of diabetes
Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
Documented diabetes by American Diabetes Association (ADA) and/or World Health Organization (WHO) criteria (see Procedures Manual for definitions) Able and willing to provide informed consent.

Meets at least all of the following ocular criteria criteria:

Presence of PDR which the investigator intends to manage with PRP alone but for which PRP can be deferred for at least 4 weeks in the setting of intravitreal ranibizumab, in the investigator's judgment.
Best corrected Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity letter score > 24 (approximate Snellen equivalent 20/320) on the day of randomization.
Media clarity, pupillary dilation, and study participant cooperation sufficient to administer PRP and obtain adequate fundus photographs and optical coherence tomography (OCT).
- Investigator must verify accuracy of OCT scan by ensuring it is centered and of adequate quality

Exclusion criteria

Exclusion Criteria:

Significant renal disease, defined as a 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).

Individuals in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 4 months should not be enrolled.

Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval for the indication being studied.

Study participants cannot receive another investigational drug while participating in the study.

Known allergy to any component of the study drug.

Blood pressure > 180/110 (systolic above 180 or diastolic above 110).

If blood pressure is brought below 180/110 by anti-hypertensive treatment, individual can become eligible.

Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.

Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization.

These drugs should not be used during the study.

For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years.

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 Diabetic Retinopathy Clinical Research Network (DRCR.net) certified clinical center during the 3 years of the study.

Individual has any of the following ocular characteristics:

History of prior panretinal photocoagulation (prior PRP is defined as ≥ 100 burns outside of the posterior pole)
Tractional retinal detachment involving the macula.
-- A tractional retinal detachment is not an exclusion if it is outside of the posterior pole (not threatening the macula) and in the investigator's judgment, is not a contraindication to intravitreal ranibizumab treatment and also does not preclude deferring PRP for at least 4 weeks in the setting of intravitreal ranibizumab
Exam evidence of neovascularization of the angle (neovascularization of the iris alone is not an exclusion if it does not preclude deferring PRP for at least 4 weeks in the investigator's judgment).
If macular edema is present, it is considered to be primarily due to a cause other than diabetic macular edema.
-- An eye should not be considered eligible if:
- macular edema is present that is considered to be related to ocular surgery such as cataract extraction or
- clinical exam and/or OCT suggest that vitreoretinal interface abnormalities disease (e.g., a taut posterior hyaloid or epiretinal membrane) is the primary cause of any macular edema.
An ocular condition is present (other than diabetic retinopathy) that, in the opinion of the investigator, might alter visual acuity during the course of the study (e.g., retinal vein or artery occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.).
-- A vitreous or preretinal hemorrhage is not an exclusion if it is out of the visual axis and in the investigator's judgment is not having any affect on visual acuity.
Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye were otherwise normal).
History of intravitreal anti-VEGF treatment at any time in the past 2 months.
History of corticosteroid treatment (intravitreal or peribulbar) at any time in the past 4 months.
--If the investigator believes that there may still be a substantial effect 4 months after prior treatment (e.g., dose of intravitreal triamcinolone higher than 4 mg), the eye should not be included.
History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.
History of (yttrium-aluminum-garnet) YAG capsulotomy performed within 2 months prior to randomization.
Aphakia.
Uncontrolled glaucoma (in investigator's judgment).
Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 305 participants (actual)

Study arms

Experimental
Anti-VEGF+Deferred PRP
Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.
Drug: 0.5-mg Ranibizumab · Other: Deferred panretinal photocoagulation
Active comparator
Prompt PRP
PRP= Panretinal Photocoagulation. PRP alone.
Other: Prompt Panretinal Photocoagulation

Interventions

OtherPrompt Panretinal Photocoagulation
Panretinal photocoagulation alone at baseline (full session completed within 56 days).
Drug0.5-mg Ranibizumab
Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
OtherDeferred panretinal photocoagulation
PRP is deferred until failure/futility criteria for intravitreal injection are met.

What researchers measure

Primary outcomes

Mean Change in Visual Acuity From Baseline
Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.
Time frame: 2-years

Secondary outcomes

Mean Visual Acuity
Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.
Time frame: 2-years
Number of Eyes With Greater Than or Equal to 10 Letter Vision Gain
Time frame: 2-years
Humphrey Visual Field Test Cumulative Score Change From Baseline
Visual fields, collected using the Humphrey Visual Field analyzer, measured the total point score (sum of retinal sensitivities of all points) tested on 30-2 and 60-4 patterns, which included the mid-peripheral and peripheral visual fields. A lower score indicates greater visual field loss.The cumulative score is the sum of all visual field sensitivity values for each of the four individual quadrants of the visual field (the quadrants are divided by the horizontal and vertical lines). The range can be from 0 to about 600 for the 30-2 test \[for each quadrant\], and from 0 to about 400 or 450 for the peripheral test.
Time frame: 2-years
Frequency of Vitrectomy
Time frame: 2-years
Mean Change in OCT Central Subfield Thickness From Baseline
All baseline and 2-year optical coherence tomography (OCT) scans were evaluated by the OCT reading center.
Time frame: 2-years
Development of Central DME With Vision Impairment by 2-years
Time frame: 2-years
Number of Eyes With Vitreous Hemorrhage
Time frame: 2-years
Number of Eyes Without Active or Regressed Neovascularization on Fundus Photography at 2-years
Time frame: 2-years
Number of Eyes With Greater Than or Equal to 10 Letter Vision Loss
Time frame: 2-year

Results

Posted Jun 1, 2016

Participant flow

Participants with 2 eyes in the study had 1 eye randomly assigned to receive ranibizumab and 1 eye to receive panretinal photocoagulation. Two-year completed visits include those that occurred between 644 and 812 days (between 92 and 116 weeks).

Participant flow — Overall Study
Milestone	Anti-VEGF+Deferred PRP	Prompt PRP
Started	191	203
Completed	160	168
Not completed	31	35
Withdrew: Withdrawal by subject	20	23
Withdrew: Death	10	8
Withdrew: Missed visit	1	4

Outcome measures

PrimaryMean Change in Visual Acuity From Baseline

Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.

Time frame:: 2-years
Reported as:: Mean · letters

Mean Change in Visual Acuity From Baseline
letters	Anti-VEGF+Deferred PRP	Prompt PRP
Mean Change in Visual Acuity From Baseline	2.8 (0.4 to 5.2)	0.2 (-1.9 to 2.3)

SecondaryMean Visual Acuity

Time frame:: 2-years
Reported as:: Mean · letters

Mean Visual Acuity
letters	Anti-VEGF+Deferred PRP	Prompt PRP
Mean Visual Acuity	78.7 ± 16.3	76.2 ± 14.1

SecondaryNumber of Eyes With Greater Than or Equal to 10 Letter Vision Gain

Time frame:: 2-years
Reported as:: Number · eyes

Number of Eyes With Greater Than or Equal to 10 Letter Vision Gain
eyes	Anti-VEGF+Deferred PRP	Prompt PRP
Number of Eyes With Greater Than or Equal to 10 Letter Vision Gain	35	31

SecondaryHumphrey Visual Field Test Cumulative Score Change From Baseline

Visual fields, collected using the Humphrey Visual Field analyzer, measured the total point score (sum of retinal sensitivities of all points) tested on 30-2 and 60-4 patterns, which included the mid-peripheral and peripheral visual fields. A lower score indicates greater visual field loss.The cumulative score is the sum of all visual field sensitivity values for each of the four individual quadrants of the visual field (the quadrants are divided by the horizontal and vertical lines). The range can be from 0 to about 600 for the 30-2 test \[for each quadrant\], and from 0 to about 400 or 450 for the peripheral test.

Time frame:: 2-years
Reported as:: Median · decibels

Humphrey Visual Field Test Cumulative Score Change From Baseline
decibels	Anti-VEGF+Deferred PRP	Prompt PRP
Humphrey Visual Field Test Cumulative Score Change From Baseline	-25 (-232 to 223)	-379 (-723 to -75)

SecondaryFrequency of Vitrectomy

Time frame:: 2-years
Reported as:: Number · eyes

Frequency of Vitrectomy
eyes	Anti-VEGF+Deferred PRP	Prompt PRP
Frequency of Vitrectomy	8	30

SecondaryMean Change in OCT Central Subfield Thickness From Baseline

All baseline and 2-year optical coherence tomography (OCT) scans were evaluated by the OCT reading center.

Time frame:: 2-years
Reported as:: Mean · µm

Mean Change in OCT Central Subfield Thickness From Baseline
µm	Anti-VEGF+Deferred PRP	Prompt PRP
Mean Change in OCT Central Subfield Thickness From Baseline	-47 (-61 to -33)	-3 (-15 to 9)

SecondaryDevelopment of Central DME With Vision Impairment by 2-years

Time frame:: 2-years
Reported as:: Number · eyes

Development of Central DME With Vision Impairment by 2-years
eyes	Anti-VEGF+Deferred PRP	Prompt PRP
Development of Central DME With Vision Impairment by 2-years	15	42

SecondaryNumber of Eyes With Vitreous Hemorrhage

Time frame:: 2-years
Reported as:: Number · Eyes

Number of Eyes With Vitreous Hemorrhage
Eyes	Anti-VEGF+Deferred PRP	Prompt PRP
Number of Eyes With Vitreous Hemorrhage	52	69

SecondaryNumber of Eyes Without Active or Regressed Neovascularization on Fundus Photography at 2-years

Time frame:: 2-years
Reported as:: Number · eyes

Number of Eyes Without Active or Regressed Neovascularization on Fundus Photography at 2-years
eyes	Anti-VEGF+Deferred PRP	Prompt PRP
Number of Eyes Without Active or Regressed Neovascularization on Fundus Photography at 2-years	49	44

SecondaryNumber of Eyes With Greater Than or Equal to 10 Letter Vision Loss

Time frame:: 2-year
Reported as:: Number · eyes

Number of Eyes With Greater Than or Equal to 10 Letter Vision Loss
eyes	Anti-VEGF+Deferred PRP	Prompt PRP
Number of Eyes With Greater Than or Equal to 10 Letter Vision Loss	15	23

Adverse events

Non-serious events are listed at a .00001% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Bilateral Participants	—	36/89 (40.4%)	85/89 (95.5%)
Anti-VEGF+Deferred PRP	—	50/102 (49%)	96/102 (94.1%)
Prompt PRP	—	43/114 (37.7%)	105/114 (92.1%)

Most frequent serious events

Showing 10 of 128

Most frequent serious events
Event	Bilateral Participants	Anti-VEGF+Deferred PRP	Prompt PRP
Renal failureRenal and urinary disorders	1/89	7/102	2/114
Cardiac failure congestiveCardiac disorders	2/89	6/102	2/114
Chest painGeneral disorders	2/89	5/102	3/114
Localised infectionInfections and infestations	4/89	3/102	1/114
PneumoniaRespiratory, thoracic and mediastinal disorders	4/89	4/102	2/114
Diabetic ketoacidosisEndocrine disorders	0/89	4/102	3/114
Renal failure chronicRenal and urinary disorders	1/89	4/102	3/114
Myocardial infarctionCardiac disorders	3/89	3/102	2/114
DeathGeneral disorders	1/89	3/102	2/114
SyncopeNervous system disorders	0/89	3/102	1/114

Most frequent other events

Showing 10 of 402

Most frequent other events
Event	Bilateral Participants	Anti-VEGF+Deferred PRP	Prompt PRP
Vitreous haemorrhageEye disorders	37/89	46/102	49/114
Vitreous floatersEye disorders	38/89	32/102	35/114
Vision blurredEye disorders	33/89	25/102	26/114
Eye painEye disorders	22/89	14/102	21/114
HypertensionVascular disorders	13/89	24/102	18/114
Visual acuity reducedEye disorders	17/89	20/102	20/114
HeadacheNervous system disorders	15/89	10/102	18/114
NasopharyngitisRespiratory, thoracic and mediastinal disorders	15/89	17/102	10/114
Retinal detachmentEye disorders	12/89	13/102	19/114
Conjunctival haemorrhageEye disorders	10/89	16/102	9/114

Baseline characteristics

Units in Eyes

Age, Customized
Age, Customized(years)	Anti-VEGF+Deferred PRP	Prompt PRP	Total
Median	52 (44 to 59)	51 (44 to 59)	51 (44 to 59)

Sex/Gender, Customized
Sex/Gender, Customized(eyes)	Anti-VEGF+Deferred PRP	Prompt PRP	Total
Female	83	92	175
Male	108	111	219

Race/Ethnicity, Customized
Race/Ethnicity, Customized(eyes)	Anti-VEGF+Deferred PRP	Prompt PRP	Total
White	100	101	201
Hispanic	48	51	99
Black/African American	38	43	81
Asian	2	3	5
American Indian/Alaskan Native	1	0	1
More than 1 race	0	2	2
Unknown/not reported	2	3	5

Number of study eyes
Number of study eyes(eyes)	Anti-VEGF+Deferred PRP	Prompt PRP	Total
One	102	114	216
Two (one in each group)	89	89	178

Diabetes Type
Diabetes Type(eyes)	Anti-VEGF+Deferred PRP	Prompt PRP	Total
Type 1	43	41	84
Type 2	140	155	295
Uncertain	8	7	15

Duration of Diabetes
Duration of Diabetes(years)	Anti-VEGF+Deferred PRP	Prompt PRP	Total
Median	18 (12 to 24)	17 (11 to 23)	18 (11 to 24)

Hemoglobin A1c
Hemoglobin A1c(percent)	Anti-VEGF+Deferred PRP	Prompt PRP	Total
Median	8.6 (7.5 to 10.4)	8.9 (7.5 to 10.4)	8.7 (7.5 to 10.4)

Prior Myocardial Infarction
Prior Myocardial Infarction(eyes)	Anti-VEGF+Deferred PRP	Prompt PRP	Total
Number	3	4	7

12 further baseline measures are reported on the registry.

Study locations

48 sites

Retinal Consultants of AZ
Phoenix, Arizona 85014, United States
Loma Linda University Health Care, Dept. of Ophthalmology
Loma Linda, California 92354, United States
Southern California Desert Retina Consultants, MC
Palm Springs, California 92262, United States
California Retina Consultants
Santa Barbara, California 93103, United States
Bay Area Retina Associates
Walnut Creek, California 94598, United States
New England Retina Associates
Trumbull, Connecticut 06611, United States
Retina Consultants of Southwest Florida
Fort Myers, Florida 33912, United States
Central Florida Retina Institute
Lakeland, Florida 33805, United States
Ocala Eye Retina Consultants
Ocala, Florida 34474, United States
Fort Lauderdale Eye Institute
Plantation, Florida 33324, United States
Retina Associates of Sarasota
Venice, Florida 34285, United States
Southeast Retina Center, P.C.
Augusta, Georgia 30909, United States
North Shore University Health System
Glenview, Illinois 60026, United States
Raj K. Maturi, M.D., P.C.
Indianapolis, Indiana 46290, United States
John-Kenyon American Eye Institute
New Albany, Indiana 47150, United States
Wolfe Eye Clinic
West Des Moines, Iowa 50266, United States
Retina and Vitreous Associates of Kentucky
Lexington, Kentucky 40509-1802, United States
Paducah Retinal Center
Paducah, Kentucky 42001, United States
Elman Retina Group, P.A.
Baltimore, Maryland 21237, United States
Vitreo-Retinal Associates, PC
Worcester, Massachusetts 01605, United States
Retina Vitrous Center
Grand Blanc, Michigan 48439, United States
Barnes Retina Institute
Saint Louis, Missouri 63110, United States
Eye Surgical Associates
Lincoln, Nebraska 38506, United States
The New York Eye and Ear Infirmary/Faculty Eye Practice
New York, New York 10003, United States
University of Rochester
Rochester, New York 14642, United States
Retina-Vitreous Surgeons of Central New York, PC
Syracuse, New York 13224, United States
University of North Carolina
Chapel Hill, North Carolina 27599-7040, 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
Retina Northwest, PC
Portland, Oregon 97210, United States
Casey Eye Institute
Portland, Oregon 97239, United States
Penn State College of Medicine
Hershey, Pennsylvania 17033, United States
Family Eye Group
Lancaster, Pennsylvania 17601-2644, United States
Retina Vitrous Consultants
Pittsburgh, Pennsylvania 15213, United States
Carolina Retina Center
Columbia, South Carolina 29223, United States
Southeastern Retina Associates, PC
Kingsport, Tennessee 37660, United States
Southeastern Retina Associates, P.C.
Knoxville, Tennessee 37909, United States
Austin Retina Associates
Austin, Texas 78705, United States
Retina Research Center
Austin, Texas 78705, United States
Texas Retina Associates
Dallas, Texas 75231, United States
Retina and Vitreous of Texas
Houston, Texas 77025, United States
Baylor Eye Physicians and Surgeons
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
University of Washington Medical Center
Seattle, Washington 98195, United States
Spokane Eye Clinic
Spokane, Washington 99204, United States
Medical College of Wiconsin
Milwaukee, Wisconsin 53226, United States

References and documents

Publications

Gross JG, Glassman AR. A Novel Treatment for Proliferative Diabetic Retinopathy: Anti-Vascular Endothelial Growth Factor Therapy. JAMA Ophthalmol. 2016 Jan;134(1):13-4. doi: 10.1001/jamaophthalmol.2015.5079. No abstract available. PubMed 26583372 ↗
Gross JG, Glassman AR. Panretinal Photocoagulation vs Anti-Vascular Endothelial Growth Factor for Proliferative Diabetic Retinopathy-Reply. JAMA Ophthalmol. 2016 Jun 1;134(6):716. doi: 10.1001/jamaophthalmol.2016.0703. No abstract available. PubMed 27101313 ↗
Beaulieu WT, Bressler NM, Melia M, Owsley C, Mein CE, Gross JG, Jampol LM, Glassman AR; Diabetic Retinopathy Clinical Research Network. Panretinal Photocoagulation Versus Ranibizumab for Proliferative Diabetic Retinopathy: Patient-Centered Outcomes From a Randomized Clinical Trial. Am J Ophthalmol. 2016 Oct;170:206-213. doi: 10.1016/j.ajo.2016.08.008. Epub 2016 Aug 12. PubMed 27523491 ↗
Bressler SB, Beaulieu WT, Glassman AR, Gross JG, Jampol LM, Melia M, Peters MA, Rauser ME; Diabetic Retinopathy Clinical Research Network. Factors Associated with Worsening Proliferative Diabetic Retinopathy in Eyes Treated with Panretinal Photocoagulation or Ranibizumab. Ophthalmology. 2017 Apr;124(4):431-439. doi: 10.1016/j.ophtha.2016.12.005. Epub 2017 Feb 1. Erratum In: Ophthalmology. 2017 Sep;124(9):1427-1430. doi: 10.1016/j.ophtha.2017.06.023. PubMed 28161147 ↗
Hutton DW, Stein JD, Bressler NM, Jampol LM, Browning D, Glassman AR; Diabetic Retinopathy Clinical Research Network. Cost-effectiveness of Intravitreous Ranibizumab Compared With Panretinal Photocoagulation for Proliferative Diabetic Retinopathy: Secondary Analysis From a Diabetic Retinopathy Clinical Research Network Randomized Clinical Trial. JAMA Ophthalmol. 2017 Jun 1;135(6):576-584. doi: 10.1001/jamaophthalmol.2017.0837. PubMed 28492920 ↗
Gross JG, Glassman AR, Klein MJ, Jampol LM, Ferris FL 3rd, Bressler NM, Beck RW. Interim Safety Data Comparing Ranibizumab With Panretinal Photocoagulation Among Participants With Proliferative Diabetic Retinopathy. JAMA Ophthalmol. 2017 Jun 1;135(6):672-673. doi: 10.1001/jamaophthalmol.2017.0969. PubMed 28492921 ↗
Jampol LM, Odia I, Glassman AR, Baker CW, Bhorade AM, Han DP, Jaffe GJ, Melia M, Bressler NM, Tanna AP; Diabetic Retinopathy Clinical Research Network. PANRETINAL PHOTOCOAGULATION VERSUS RANIBIZUMAB FOR PROLIFERATIVE DIABETIC RETINOPATHY: Comparison of Peripapillary Retinal Nerve Fiber Layer Thickness in a Randomized Clinical Trial. Retina. 2019 Jan;39(1):69-78. doi: 10.1097/IAE.0000000000001909. PubMed 29135802 ↗
Bressler SB, Beaulieu WT, Glassman AR, Gross JG, Melia M, Chen E, Pavlica MR, Jampol LM; Diabetic Retinopathy Clinical Research Network. Panretinal Photocoagulation Versus Ranibizumab for Proliferative Diabetic Retinopathy: Factors Associated with Vision and Edema Outcomes. Ophthalmology. 2018 Nov;125(11):1776-1783. doi: 10.1016/j.ophtha.2018.04.039. Epub 2018 Jul 3. PubMed 29980333 ↗
Gross JG, Glassman AR, Liu D, Sun JK, Antoszyk AN, Baker CW, Bressler NM, Elman MJ, Ferris FL 3rd, Gardner TW, Jampol LM, Martin DF, Melia M, Stockdale CR, Beck RW; Diabetic Retinopathy Clinical Research Network. Five-Year Outcomes of Panretinal Photocoagulation vs Intravitreous Ranibizumab for Proliferative Diabetic Retinopathy: A Randomized Clinical Trial. JAMA Ophthalmol. 2018 Oct 1;136(10):1138-1148. doi: 10.1001/jamaophthalmol.2018.3255. Erratum In: JAMA Ophthalmol. 2019 Apr 1;137(4):467. doi: 10.1001/jamaophthalmol.2019.0032. PubMed 30043039 ↗
Sun JK, Glassman AR, Beaulieu WT, Stockdale CR, Bressler NM, Flaxel C, Gross JG, Shami M, Jampol LM; Diabetic Retinopathy Clinical Research Network. Rationale and Application of the Protocol S Anti-Vascular Endothelial Growth Factor Algorithm for Proliferative Diabetic Retinopathy. Ophthalmology. 2019 Jan;126(1):87-95. doi: 10.1016/j.ophtha.2018.08.001. Epub 2018 Aug 7. PubMed 30096354 ↗
Bressler SB, Beaulieu WT, Glassman AR, Gross JG, Melia M, Chen E, Pavlica MR, Jampol LM; Diabetic Retinopathy Clinical Research Network. PHOTOCOAGULATION VERSUS RANIBIZUMAB FOR PROLIFERATIVE DIABETIC RETINOPATHY: Should Baseline Characteristics Affect Choice of Treatment? Retina. 2019 Sep;39(9):1646-1654. doi: 10.1097/IAE.0000000000002377. PubMed 30807516 ↗
Glassman AR, Beaulieu WT, Stockdale CR, Beck RW, Bressler NM, Labriola LT, Melia M, Oliver K, Sun JK. Effect of telephone calls from a centralized coordinating center on participant retention in a randomized clinical trial. Clin Trials. 2020 Apr;17(2):195-201. doi: 10.1177/1740774519894229. Epub 2020 Jan 27. PubMed 31984762 ↗
Maguire MG, Liu D, Glassman AR, Jampol LM, Johnson CA, Baker CW, Bressler NM, Gardner TW, Pieramici D, Stockdale CR, Sun JK; DRCR Retina Network. Visual Field Changes Over 5 Years in Patients Treated With Panretinal Photocoagulation or Ranibizumab for Proliferative Diabetic Retinopathy. JAMA Ophthalmol. 2020 Mar 1;138(3):285-293. doi: 10.1001/jamaophthalmol.2019.5939. PubMed 31999300 ↗
Hutton DW, Stein JD, Glassman AR, Bressler NM, Jampol LM, Sun JK; DRCR Retina Network. Five-Year Cost-effectiveness of Intravitreous Ranibizumab Therapy vs Panretinal Photocoagulation for Treating Proliferative Diabetic Retinopathy: A Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2019 Dec 1;137(12):1424-1432. doi: 10.1001/jamaophthalmol.2019.4284. PubMed 31647496 ↗
Writing Committee for the Diabetic Retinopathy Clinical Research Network; Gross JG, Glassman AR, Jampol LM, Inusah S, Aiello LP, Antoszyk AN, Baker CW, Berger BB, Bressler NM, Browning D, Elman MJ, Ferris FL 3rd, Friedman SM, Marcus DM, Melia M, Stockdale CR, Sun JK, Beck RW. Panretinal Photocoagulation vs Intravitreous Ranibizumab for Proliferative Diabetic Retinopathy: A Randomized Clinical Trial. JAMA. 2015 Nov 24;314(20):2137-2146. doi: 10.1001/jama.2015.15217. Erratum In: JAMA. 2016 Mar 1;315(9):944. doi: 10.1001/jama.2016.1591. JAMA. 2019 Mar 12;321(10):1008. doi: 10.1001/jama.2019.0265. PubMed 26565927 ↗
Maguire MG, Liu D, Bressler SB, Friedman SM, Melia M, Stockdale CR, Glassman AR, Sun JK; DRCR Retina Network. Lapses in Care Among Patients Assigned to Ranibizumab for Proliferative Diabetic Retinopathy: A Post Hoc Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2021 Dec 1;139(12):1266-1273. doi: 10.1001/jamaophthalmol.2021.4103. PubMed 34673898 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01489189
Lead sponsor: Jaeb Center for Health Research
Collaborators: National Eye Institute (NEI), Genentech, Inc.
Responsible party: Sponsor
First posted: Dec 9, 2011
Start date: Mar 2012
Primary completion: Jan 2015
Completion: Feb 5, 2018
Results posted: Jun 1, 2016
Last update: Oct 29, 2021

Study contacts

Jeffrey G Gross, MD

study chair · Carolina Retina Center

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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