Patients with type I or type II diabetes mellitus and high risk diabetic retinopathy. MedDRA version: 14.1 Level: LLT Classification code 10036857 Term: Proliferative diabetic retinopathy System Organ Class: 100000004853
Conditions
Interventions
Trade Name: Lucentis - 10 mg / ml solution for injection
Product Name: Lucentis - 10 mg / ml solution for injection
Pharmaceutical Form: Solution for injection
INN or Proposed INN: RANIBIZUMAB
CAS Num
Sponsors
AIBILI - Association for Innovation and Biomedical Research on Light and Image
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.High-risk proliferative diabetic retinopathy (HR-PDR); i. Neovascularization in the disc = 1/4 disc area OR Neovascularization Elsewhere = 1/2 disc area; ii. Neovascularization Elsewhere =65 years) yes F.1.3.1 Number of subjects for this age range 47
Exclusion criteria
Exclusion criteria: 1. Any intraocular surgery within 6 months before trial enrolment, including: a. Prior scatter (panretinal) or focal/grid photocoagulation; b. Eyes who have received YAG laser, or peripheral retinal cryoablation, or laser retinopexy (for retinal tears only); 2. Fibrovascular proliferation with retinal traction; 3. Other cause of retinal Neovascularization (retinal vein occlusion, radiation retinopathy or others); 4. Atrophy/scarring/fibrosis/ hard exudates involving the centre of the macula; 5. Significant media opacities or inadequate pupillary dilation, which might interfere with visual acuity, assessment of toxicity or fundus photography; 6. Any likelihood that the subject will require cataract surgery within the following 1 year; 7. Diabetic macular edema with central involvement, i.e., central macular thickness (Central Point Thickness) > 300 µm (Stratus OCT) equivalent values measured by SD-OCT, adjusted according to the SD-OCT machine used; 8. Previous vitrectomy; 9. Intraocular pressure > 21 mmHg; 10. Previous anti-VEGF therapy within the last 3 months; 11. Previous treatment with periocular and/or intravitreal corticosteroids within the last 3 months; 12. Known serious allergies or history of hypersensitivity to fluorescein used in angiography, or to components of Lucentis® formulation; 13. Acute ocular or periocular infection; 14. Active severe ocular or periocular inflammation; 15. Previous filtering surgery (e.g., trabeculectomy) or placement of a glaucoma drainage device (e.g., tube-shunt surgery). 16. Systolic BP > 170 mmHg or diastolic BP > 100 mmHg; 17. HbA1C level >11% or recent signs of uncontrolled diabetes; 18. Any of the following underlying systemic diseases: a. 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; b. History or evidence of clinically significant peripheral vascular disease such as intermittent claudication or prior amputation; c. Renal failure requiring dialysis or renal transplant or renal insufficiency with creatinine levels > 2.0 mg/dl at screening; d. Stroke (within 12 months of trial entry); e. Any major surgical procedure within one month before trial enrolment; 19. Subject with a condition (such as advanced, severe or unstable disease or its treatment) or is in a situation which may put him/her at significant risk, which may confound the study results or may interfere significantly with the subject’s participation in the study; 20. Previous radiation to the head in the region of the study eye; 21. Use of any other investigational drugs within the last 3 months (for Diabetic Retinopathy or other condition); 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. 24. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant UNLESS they are: 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,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of ranibizumab 0.5 mg intravitreal injections plus panretinal photocoagulation versus panretinal photocoagulation alone on the regression of the neovascularization area in patients with high-risk proliferative diabetic retinopathy over a 12-month treatment period.;Secondary Objective: To compare the following parameters between the two treatment arms: - Changes in Best Corrected Visual Acuity from baseline to Month-12. - Time to complete neovascularization regression. - Recurrence of neovascularization. - Changes in the macular retinal thickness assessed by Optical Coherent Tomography from the baseline to Month-12. - Need of treatment for diabetic macular edema. - Need of vitrectomy due to the occurrence of vitreous haemorrhage, tractional retinal detachment or other complications of diabetic retinopathy. - Treatment safety profile.;Primary end point(s): Regression of neovascularization, defined as any decrease in the area of neovascularization, from the baseline to Month-12;Timepoint(s) of evaluation of this end point: Screening Visit, Month 3, Month 7 and Month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Best-corrected visual acuity - changes from baseline to Month 12 - Time to complete neovascularization regression - Recurrence of neovascularization - Macular retinal thickness - changes from baseline to Month 12, assessed by OCT - Need of treatment for Diabetic Macular Edema - Need of vitrectomy due to the occurrence of vitreous hemorrhage, tractional retinal detachment or other complications of diabetic retinopathy - Adverse events related to the treatments.;Timepoint(s) of evaluation of this end point: Screening Visit, Month 3, Month 7 and Month 12 | — |
Countries
France, Italy, Portugal, United Kingdom
Contacts
Public Contact4C- CCC for Clinical Research
AIBILI - Association for Innovation and Biomedical Research on Light and Image
Outcome results
None listed