Retrospective Review of Proliferative Diabetic Retinopathy Patients

Current standard treatment for Proliferative Diabetic Retinopathy (PDR) is panretinal
photocoagulation (PRP), but this treatment is inherently destructive and has several
potential adverse effects on aspects of visual function, including constriction of peripheral
visual fields and decreases in night vision, contrast sensitivity and color perception. Thus,
therapeutic alternatives that might delay or obviate the need for PRP are desirable. It has
been demonstrated that retinal neovascularization from PDR is highly responsive to anti-VEGF
therapy, but it is unclear how long regression of retinal neovascularization is sustained
after anti- VEGF therapy is halted in clinical practice.

It is possible that intravitreal ranibizumab treatment could prevent laser-associated vision
loss by precluding the need for PRP as long as the eye continued to receive ranibizumab. Even
if ranibizumab treatment was discontinued, it is possible that initial treatment with
anti-VEGF therapy might improve visual outcomes substantially by delaying or preventing the
need for PRP, and the infrequent frequency of administration of ranibizumab for DME (median 2
to 3 times in the second year of treatment) after the DME initially has resolved on anti-VEGF
therapy suggests that monthly ranibizumab might not be needed to achieve control of PDR.

The Diabetic Retinopathy Clinical Research Network (DRCR network) is currently evaluating
intravitreal ranibizumab treatment to see if can prevent laser-associated vision loss by
precluding the need for PRP as long as the eye continued to receive ranibizumab. However,
intravitreal injections carry the risk of serious complications. Ophthalmic complications
include endophthalmitis in 2% of all injected patients cumulatively. Endophthalmitis is a
vision threatening and can cause severe and permanent vision loss and even loss of the eye.
Other complications include vitreous hemorrhage, retinal detachment, uveitis and glaucoma.
This study will evaluate ranibizumab usage as the primary treatment for PDR in a busy private
clinical practice.

Inclusion Criteria:

1. Age >= 18 years Individuals <18 years old are not being included because PDR is so
rare in this age group that the diagnosis of PDR may be questionable.

2. 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 ADA and/or WHO criteria (see Procedures Manual for
definitions

3. Presence of PDR which the investigator has treated the study eye(s) with ranibizumab

Exclusion Criteria:

1. History of prior panretinal photocoagulation prior to initiating ranibizumab

2. 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)

3. History of vitrectomy prior to initiating ranibizumab

4. Treatment with Ranibizumab within six months of treatment regimen