Neovacular Age-related Macular Degeneration Clinical Trial
— UNRAVELOfficial title:
A 3 Months, patient-and Rater Blinded, Randomized, Prospective Study Comparing Systemic Anti-VEGF Effects Between Ranibizumab and Aflibercept in Treatment naïve Neovascular Age-related Macular Degeneration (nAMD) Patients
This study will assess systemic VEGF level in patients with neovascular Age-related Macular Degeneration following treatment with Ranibizumab or Aflibercept
| Status | Completed |
| Enrollment | 195 |
| Est. completion date | September 2015 |
| Est. primary completion date | September 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years and older |
| Eligibility |
Inclusion Criteria: - Newly diagnosed AMD - No previous treatment received for diagnosed AMD - Visual Acuity 6/7.5 to 6/96 Exclusion Criteria: - standard exclusion criteria for anti-VEGF treatment - Visual Acuity <6/96 - nAMD in both eyes, or any condition in other eye which may require anti-VEGF treatment during study period - other disease in candidate eye which could compromise visual acuity or require medical/surgical intervention during study period - participation to other clinical study with 'not approved' treatment within a year prior to UNRAVEL study participation. Other protocol-defined inclusion/exclusion criteria may apply |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Novartis Investigative Site | Be'er Sheva | |
| Israel | Novartis Investigative Site | Haifa | |
| Israel | Novartis Investigative Site | Haifa | |
| Israel | Novartis Investigative Site | Kfar-Sava | |
| Israel | Novartis Investigative Site | Petach Tikva | |
| Israel | Novartis Investigative Site | Rehovot | |
| Israel | Novartis Investigative Site | Tel-Aviv | |
| Korea, Republic of | Novartis Investigative Site | Daegu | |
| Korea, Republic of | Novartis Investigative Site | Seoul | |
| Korea, Republic of | Novartis Investigative Site | Seoul | |
| Korea, Republic of | Novartis Investigative Site | Seoul | Korea |
| Korea, Republic of | Novartis Investigative Site | Seoul | Korea |
| Malaysia | Novartis Investigative Site | Kuala Lumpur | |
| Malaysia | Novartis Investigative Site | Petaling Jaya | Selangor Darul Ehsan |
| Philippines | Novartis Investigative Site | Makati City | |
| Philippines | Novartis Investigative Site | Pasig City | |
| Philippines | Novartis Investigative Site | Quezon City | |
| Singapore | Novartis Investigative Site | Singapore | |
| Singapore | Novartis Investigative Site | Singapore | |
| Taiwan | Novartis Investigative Site | Lin-Kou | |
| Taiwan | Novartis Investigative Site | Taipei | |
| Thailand | Novartis Investigative Site | Bangkok | Bangkoknoi |
| Thailand | Novartis Investigative Site | Bangkok | |
| Thailand | Novartis Investigative Site | Bangkok |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
Israel, Korea, Republic of, Malaysia, Philippines, Singapore, Taiwan, Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percent reduction in blood VEGF at month 3 following intravitreal (IVT) injection of anti-VEGF agent | Percent reduction in blood VEGF level is calculated as the difference in blood VEGF level mesured after 3 month of anti-VEGF agent IVT treatment (Ranibizumab or Aflibercept) when compared to baseline blood VEGF level. | Month 3 | Yes |
| Secondary | Percent reduction in blood VEGF level overtime | Blood VEGF measurement performed at all visits and compared to baseline level | baseline to month 3 | Yes |
| Secondary | Correlation between blood detected VEGF level and measured concentration of anti-VEGF agent overtime | VEGF level and anti-VEGF concentration measured in the blood at each single visit, including pre- and post-dose measurement during the dosing visits. | baseline through month 3 | Yes |
| Secondary | Mean change from baseline in Best Corrected Visual Acuity (BCVA) of the study eye over time | BCVA score is assessed on study eye at every study visit based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity charts at a testing distance of 4 meters. An increase in score indicates an improvement in acuity | baseline through Month 3 | No |
| Secondary | mean change in central retinal thickness (CRT) of the study eye over time | Central Retinal Thickness in micrometers assessed by Optical Tomography (OCT) at each single study visit. A reduction is thickness indicates an improvement is the lesion area. | baseline through Month 3 | No |
| Secondary | Number of ocular and systemic Adverse Events | Number of reported ocular and systemic AEs | Baseline through Month 3 | Yes |