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Phase 3 N=394 Randomized Treatment

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

Proliferative Diabetic Retinopathy

Enrolled (actual)
394
Serious AEs
42.3%
Results posted
Jun 2016
Primary outcome: Primary: Mean Change in Visual Acuity From Baseline — 2.8; 0.2 letters

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Prompt Panretinal Photocoagulation (Other); 0.5-mg Ranibizumab (Drug); Deferred panretinal photocoagulation (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Jaeb Center for Health Research
Primary completion
Jan 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean Change in Visual Acuity From Baseline
2.8; 0.2
SECONDARY
Mean Visual Acuity
78.7; 76.2
SECONDARY
Number of Eyes With Greater Than or Equal to 10 Letter Vision Gain
35; 31
SECONDARY
Humphrey Visual Field Test Cumulative Score Change From Baseline
-25; -379
SECONDARY
Frequency of Vitrectomy
8; 30
SECONDARY
Mean Change in OCT Central Subfield Thickness From Baseline
-47; -3
SECONDARY
Development of Central DME With Vision Impairment by 2-years
15; 42
SECONDARY
Number of Eyes With Vitreous Hemorrhage
52; 69
SECONDARY
Number of Eyes Without Active or Regressed Neovascularization on Fundus Photography at 2-years
49; 44
SECONDARY
Number of Eyes With Greater Than or Equal to 10 Letter Vision Loss
15; 23

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.

Eligibility Criteria

Inclusion Criteria

Age >= 18 years -Individuals 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

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.

  • Substan
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01489189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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