Prospective, Randomized, Open Label, Phase II Study to Assess Efficacy and Safety of Macugen® (Pegaptanib 0.3 mg Intravitreal Injections) Plus Panretinal Photocoagulation and PRP (Monotherapy) in the Treatment With High Risk PDR.

Exclusion Criteria

• •Eyes with prior scatter (panretinal).
• •Focal/grid photocoagulation, within the previous 6 months.
• •Fibrovascular proliferation with retinal traction.
• •Other cause of retinal neovascularization (retinal vein occlusion, radiation retinopathy or others).
• •Atrophy/scarring/fibrosis/ hard exudates involving the center of the macula.
• •Subjects who have received YAG laser within the previous 6 months.
• •Peripheral retinal cryoablation, or laser retinopexy (for retinal tears only),
• •Significant media opacities, which might interfere with visual acuity, assessment of toxicity or fundus photography.
• •Subjects should not be entered if there is likelihood that they will require cataract surgery within the following 1 year.
• •Any intraocular surgery within 6 months before trial enrolment.
• •Previous vitrectomy.
• •HbA1C level \>11% or recent signs of uncontrolled diabetes.
• •Any of the following underlying systemic diseases:
• •History or evidence of severe cardiac disease, e.g. NYHA Functional Class III or IV, clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction, or revascularization procedure within 6 months prior to baseline, or ventricular tachyarrhythmia requiring treatment.
• •* History or evidence of clinically significant peripheral vascular disease such as intermittent claudication or prior amputation.
• •* Clinically significant impaired renal function (serum creatinine \>2.5 mg/dL or s/p renal transplant or receiving dialysis).
• •* Clinically significant impaired hepatic function.
• •* Stroke (within 12 months of trial entry).
• •* Any major surgical procedure within one month before trial enrolment.
• •Previous radiation to the head in the region of the study eye.
• •Any prior treatment with an investigational agent for diabetic retinopathy or anti-VEGF therapy (including intravitreal, subconjunctival or subtenons corticosteroids) during the past 90 days for any other condition.
• •Known serious allergies to fluorescein used in angiography, or to components of Macugen® formulation.
• •Systolic BP \> 170 (2 different readings) or diastolic BP \> 100 (2 different readings).
• •Acute ocular or periocular infection.
• •Previous filtering surgery (e.g., trabeculectomy) or placement of a glaucoma drainage devise (e.g., tube-shunt surgery).
• •Use of other investigational drugs at the time of enrollment.
• •History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
• •History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
• •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\> 5 mIU/mL).
• •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant UNLESS they are: women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner; women whose partners have been sterilized by vasectomy or other means using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices - IUDs). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) are not acceptable.