Proliferative Diabetic Retinopathy. MedDRA version: 12.0 Level: LLT Classification code 10036857 Term: Proliferative diabetic retinopathy
Conditions
Interventions
Trade Name: Macugen 0.3 mg solution for injection
Product Name: Macugen 0.3 mg solution for injection
Product Code: S
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PEGAPTANIB SODIUM
Sponsors
AIBILI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Type I, or Type II diabetic subjects as defined by the WHO criteria of either gender, and aged = 18 years. 2. Women must be using effective contraception, be post-menopausal for at least 12 months prior to trial entry, or surgically sterile. 3. Ability to provide written informed consent. 4. Ability to return for all trial visits. 5. High-risk proliferative diabetic retinopathy (HR-PDR) eyes (as defined in section 2). 6. BCVA at baseline > 20/320 (25 letters in the ETDRS Chart) in the study eye. 7. Clear ocular media and adequate pupillary dilatation to permit good quality fundus photography. 8. Intraocular pressure =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Eyes with prior scatter (panretinal) 2. Focal/grid photocoagulation, within the previous 6 months. 3. Fibrovascular proliferation with retinal traction. 4. Other cause of retinal neovascularization (retinal vein occlusion, radiation retinopathy or others). 5. Atrophy/scarring/fibrosis/ hard exudates involving the center of the macula. 6. Subjects who have received YAG laser within the previous 6 months. 7. Peripheral retinal cryoablation, or laser retinopexy (for retinal tears only), 8. Significant media opacities, which might interfere with visual acuity, assessment of toxicity or fundus photography. 9. Subjects should not be entered if there is likelihood that they will require cataract surgery within the following 1 year. 10. Any intraocular surgery within 6 months before trial enrolment. 11. Previous vitrectomy. 12. HbA1C level >11% or recent signs of uncontrolled diabetes. 13. 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. 14. Previous radiation to the head in the region of the study eye. 15. 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. 16. Known serious allergies to fluorescein used in angiography, or to components of Macugen® formulation. 17. Systolic BP > 170 (2 different readings) or diastolic BP > 100 (2 different readings). 18. Acute ocular or periocular infection. 19. Previous filtering surgery (e.g., trabeculectomy) or placement of a glaucoma drainage devise (e.g., tube-shunt surgery). 20. Use of other investigational drugs at the time of enrollment. 21. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. 22. 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. 23. 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). 24. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study is designed to evaluate the safety and determine the efficacy of PRP monotherapy or combination therapy (PRP plus pegaptanib 0.3 mg) in the regression of retinal neovascularization in patients with Type I or Type II diabetes mellitus and with high risk proliferative diabetic retinopathy. ;Secondary Objective: To evaluate: 1. Changes from baseline in Best-Corrected Visual Acuity (BCVA) 2. Changes from baseline in macular retinal thickness by Optical Coherent Tomography (OCT) 3. Changes from baseline in Visual Fields; 4. Recurrence of neovascularization 5. Number of treatments needed 6. Additional focal or grid laser for DME 7. Drug safety profile 8. Need for vitrectomy due to occurrence of vitreous hemorrhage or retinal detachment relative to the two treatment arms.;Primary end point(s): Regression of retinal neovascularization in eyes with high-risk PDR. | — |
Countries
Portugal
Outcome results
None listed