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



Status:Completed
Conditions:Ocular, Diabetes
Therapuetic Areas:Endocrinology, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:7/12/2018
Start Date:March 2012
End Date:February 5, 2018

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Prompt Panretinal Photocoagulation Versus Intravitreal Ranibizumab With Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy

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.


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:

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
We found this trial at
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1959 NE Pacific St
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