Proliferative diabetic retinopathy MedDRA version: 18.1 Level: LLT Classification code 10036857 Term: Proliferative diabetic retinopathy System Organ Class: 100000004853
Conditions
Interventions
Trade Name: Lucentis
Product Name: Ranibizumab
Product Code: RFB002
Pharmaceutical Form: Solution for injection
INN or Proposed INN: RANIBIZUMAB
CAS Number: 347396-82-1
Current Sponsor code: RFB002
Ot
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. PDR defined by DRS (Wilkinson et al, 2003). Upon dilated ophthalmoscopy: -Neovascularization of the disc (NVD) and/or Neovascularization elsewhere (NVE) with or without additional hemorrhage 2. BCVA in study eye at least 20 ETDRS letters (20/400) 3. Type 1 or type 2 diabetes under medical surveillance / with stabilized treatment 4. HBA1c = 12% (=107 mmol/mol) 5. Patients age = 18 willing and able to give written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Proliferative vitreoretinopathy in study eye 2. Clinically significant macular edema (CSME) (according to ETDRS guidelines) with loss of foveal depression assessed by ophthalmoscopy and OCT in study eye 3. Clinically non significant macular edema (CNSME) that is likely to develop the stage of CSME with loss of foveal depression (according to ETDRS guidelines) within study period in study eye 4. Neovascularizations covering an area of = 2 disc areas within the macula (defined as area with 6mm diameter centered on the fovea), originating either from neovascularization of the disc or multiple neovascularizations elsewhere in study eye 5. Vitreous hemorrhage that impairs adequate judgment of neovascularization by investigator or vitreous hemorrhage that makes adequate treatment with laser or ranibizumab impossible in either eye 6. Vitreomacular traction either seen on clinical examination or OCT with loss of foveal depression in study eye 7. Evidence of severe vitreoretinal interface disease (e.g. epiretinal membrane), either on clinical examination or OCT in study eye 8. Severe ischemic maculopathy in study eye 9. Rubeosis iridis in either eye 10. Uncontrolled glaucoma in either eye (e.g. IOP > 24 mmHg on medications or according to investigator’s judgment) 11. Patients who are monocular or have a BCVA score in the non-study eye (fellow eye) = 20 letters (approximate Snellen equivalent of 20/400) at Visit 1 12. Patients with active or suspected ocular or periocular infections and patients with active intraocular inflammation in study eye 13. Ocular disorders in the study eye that may confound interpretation of study results, compromise visual acuity or, according to the investigator, require medical or surgical intervention during the 12-month core study period in the opinion of the investigator, including cataract, retinal vascular occlusion, retinal detachment, macular hole, macular scars, or choroidal neovascularisation (e.g., AMD, ocular histoplasmosis, or pathologic myopia) 14. Presence of a substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e. a 20/40 cataract) or is likely to progress within core study period in study eye 15. Previous treatment with PRP in study eye with more than 300 laser spots. Last PRP session within 6 months prior randomization 16. Last laser treatment for DME less than 3 months ahead of baseline visit in study eye 17. Vitrectomy/vitreoretinal surgery a. in the medical history or planned for study eye b. planned vitrectomy or vitrectomy in last 3 months for fellow eye 18. Anti-angiogenic drugs in study eye within 3 months prior randomization 19. Prior application of corticosteroid (incl. corticosteroid releasing implant, e.g. Ozurdex®) in vitreous in study eye within 6 months prior to randomization. Prior application of fluocinolonacetonid releasing implant (Iluvien®) in vitreous in study eye within 36 months prior randomization. 20. History of intravitreal corticosteroids in phakic study eye 21. Surgery (e.g. cataract surgery) within last 3 months prior randomization in study eye (...) 30. Study eyes, who have already been randomized into this trial earlier and received medication must not be included a second time 31. Any condition that, in the opinion of the investigator, would preclude participation in the study (e.g. chronic alcoholism or drug abuse, personality disorder or use of major tranquilizers,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Change of area of neovascularizations as measured by Fluorescein Angiography at month 12 (difference to baseline value).;Secondary Objective: -BCVA in all patients (ETDRS letters) -Rates of patients (given as percentages per treatment group) --with = 5/10/15 ETDRS letters gain --with no clinical relevant change (less than 5 letters gain or loss, “stable visual acuity”) --with = 5/10/15 ETDRS letters loss --with improvement in BCVA (ETDRS letters) -Change in classification of DR based on the ETDRS severity scale (assessed by FP) -Change in retinal thickness (OCT) and further anatomic outcomes -Number of treatments -Safety -Change of area of neovascularization (assessed by FLA) at month 3 -Safety -Change of area of neovascularization (assessed by FLA) at month 3;Primary end point(s): The primary variable of this study is the area of neovascularisations;Timepoint(s) of evaluation of this end point: Month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): All quantitative secondary outcomes (i.e. BCVA, CRT) will be analyzed with ANCOVA models analogous to the primary endpoint. For the binary secondary endpoints (VA gain/loss >= 15/10 letters), the absolute and relative frequencies will be tabulated. For treatment comparisons, the difference in proportions and the Odds ratio will be calculated with the respective confidence intervals and p-values.;Timepoint(s) of evaluation of this end point: month 3 and month 12 | — |
Countries
Germany
Contacts
Public ContactMedizinischer Infoservice
Novartis Pharma GmbH
Outcome results
None listed