Prevention of Macular Edema In Patients With Diabetic Retinopathy Undergoing Cataract Surgery

Diabetic retinopathy patients who are at risk of developing macular edema (defined as ≥ 30 %
increase from pre-operative baseline in central subfield macular thickness) within 90 days
following cataract surgery. Diabetic patients are defined as those who have either Type 1 or
Type 2 diabetes. The patients must have either mild, moderate, or severe non proliferative
retinopathy or treated proliferative retinopathy. Patients must be 18 years of age and older,
of any race and either sex, requiring cataract extraction with planned implantation of a
posterior chamber intraocular lens into the lens capsule.

Inclusion Criteria:

- A patient must meet the following criteria to be eligible for inclusion in the study:

1. Must be 18 years of age and older, of any race and either sex, who have a
cataract, and are planning to undergo cataract extraction by phacoemulsification
with the implantation of a posterior chamber intraocular lens into the lens
capsule

2. History of Type I or Type II diabetes

3. NPDR: non-proliferative diabetic retinopathy (mild, moderate, or severe) or
inactive proliferative disease in the study eye as defined by the International
Clinical Diabetic Retinopathy Disease Severity Scale

4. Willing and able to comply with clinic visits and study-related procedures

5. Patients must be able to understand and sign an informed consent that has been
approved by an Institutional Review Board (IRB)

6. Central subfield macular thickness ≤ 320 μm in the study eye prior to cataract
surgery as determined by SD-OCT and confirmed by the reading center

7. Absence of clinically significant macular edema (CSME) in the study eye as
detected by clinical exam

8. Patients must have visual acuity of 20/20-20/200

Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from the study:

1. Signs of vitreomacular traction or epiretinal membrane in the study eye as detected by
reading center or investigator

2. Current or previous ocular disease in the study eye that in the opinion of the
investigator may confound assessment of the macula, the retina, or central vision
other that diabetic retinopathy

3. Active proliferative diabetic retinopathy in the study eye

4. Planned multiple procedures for study eye during the cataract/IOL implantation surgery
(e.g., trabeculectomy, corneal transplant)

5. Patients who have received corneal transplants in the study eye

6. Patients with current or history of chronic or recurrent ocular infections or
inflammation in the study eye

7. Patients with a visually nonfunctional fellow eye based upon the assessment by the
investigator

8. Patients who are immunocompromised (e.g., patients receiving chemotherapy irradiation
therapy, patients with AIDS, leukemia, or cachexia) or patients receiving dialysis

9. Use of medications known to affect the macula, including hydroxychloroquinine
(Plaquenil) and phenothiozines (e.g., thioridazine [Mellaril], chloropromazine
[Thorazine]) or supplemental niacin ≥3 grams/day

10. Use of systemic steroids, NSAIDS (non-steroidal anti-inflammatory drugs), anti-VEGF
agents within 7 days prior to surgery (through study exit). Daily doses of aspirin, up
to 325 mg, will be permitted.

11. Use of topical ocular NSAIDS and steroids, in the study eye, within 7 days prior to
surgery

12. Treatment with intraocular or periocular steroids in the study eye within 3 months
prior to surgery

13. Focal photocoagulation for the treatment of diabetic macular edema in the study eye
within 6 months of the pre-operative baseline visit (Note: peripheral retina treatment
for retinal tear or lattice degeneration is permitted)

14. Intravitreal anti-VEGF (vascular endothelial growth factor) treatment in the study eye
within 6 months of the pre-operative baseline visit

15. Patients with a known hypersensitivity to NSAIDs or steroids or any component of the
study medication.

16. Use of a topical ophthalmic prostaglandin (e.g., TRAVATAN, XALATAN) within 4 days of
surgery through study exit

17. Any concurrent intraocular condition in the study eye that, in the opinion of the
investigator, could require either medical or surgical intervention during the 90 day
study period.

18. Any concurrent ocular condition in the study eye which, in the opinion of the
investigator, could either increase the risk to the patient beyond what is to be
expected from standard procedures of intraocular injection, or which otherwise may
interfere with the injection procedure or with evaluation of efficacy or safety.

19. Pregnant or breast-feeding women -