Proliferative Diabetic Retinopathy. MedDRA version: 12.0 Level: LLT Classification code 10036857 Term: Proliferative diabetic retinopathy
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 Number:
Sponsors
AIBILI - Association for Innovation and Biomedical Research on Light and Image
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Key Inclusion Criteria: 1.High-risk proliferative diabetic retinopathy (HR-PDR) eyes. 2.BCVA at baseline > 20/320 (25 letters in the ETDRS Chart) in the study eye. 3.Clear ocular media and adequate pupillary dilatation to permit good quality fundus photography. 4.Intraocular pressure =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Key Exclusion Criteria: 1.Eyes with prior scatter (panretinal) or focal/grid photocoagulation, within the previous 6 months. 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 center of the macula. 5.Subjects who have received YAG laser, or peripheral retinal cryoablation, or laser retinopexy (for retinal tears only), or focal/grid photocoagulation, within the previous 6 months. 6.Significant media opacities, which might interfere with visual acuity, assessment of toxicity or fundus photography. 7.Subjects should not be entered if there is likelihood that they will require cataract surgery within the following 1 year. 8.Any intraocular surgery within 6 months before trial enrolment. 9.Previous vitrectomy. 10.HbA1C level >11% or recent signs of uncontrolled diabetes. 11.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. 12.Previous radiation to the head in the region of the study eye. 13.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. 14.Known serious allergies to fluorescein used in angiography, or to components of Lucentis® formulation. 15.Systolic BP > 170 (2 different readings) or diastolic BP > 100 (2 different readings). 16.Acute ocular or periocular infection. 17.Previous filtering surgery (e.g., trabeculectomy) or placement of a glaucoma drainage device (e.g., tube-shunt surgery).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this trial is to evaluate safety and to compare the efficacy of intravitreous injection of ranibizumab alone (0.5 mg), versus combination of intravitreous injection of ranibizumab (0.5 mg) plus PRP, versus PRP alone in the regression of retinal neovascularization in eyes with high-risk PDR.;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.Recurrence of neovascularization 4.Number of treatments needed 5.Additional focal or grid laser for DME 6.Drug safety profile 7.Need for vitrectomy due to occurrence of vitreous hemorrhage or retinal detachment;Primary end point(s): Regression of retinal neovascularization in eyes with high-risk PDR. | — |
Countries
Portugal
Outcome results
None listed