Prompt Panretinal Photocoagulation Versus Ranibizumab+Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
Proliferative Diabetic Retinopathy
Bottom Line
View on ClinicalTrials.gov: NCT01489189 ↗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
| Outcome | Result | p-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
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
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.