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.

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and determine the efficacy of PRP monotherapy or combination therapy (pegaptanib 0.3 mg plus PRP) in patients with Type I or Type II diabetes mellitus and with high risk proliferative diabetic retinopathy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Association for Innovation and Biomedical Research on Light and Image

Criteria

Inclusion Criteria:

• High-risk proliferative diabetic retinopathy (HR-PDR) eyes (as defined in section 2).

• BCVA at baseline > 20/320 (25 letters in the ETDRS Chart) in the study eye.

• Clear ocular media and adequate pupillary dilatation to permit good quality fundus photography.

• Intraocular pressure < 21 mmHg.

• Type I, or Type II diabetic subjects as defined by the WHO criteria of either gender, and aged ≥ 18 years.

• Women must be using effective contraception, be post-menopausal for at least 12 months prior to trial entry, or surgically sterile.

• Ability to provide written informed consent.

• Ability to return for all trial visits.

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.