UNcovering the Difference Between Ranibizumab and Aflibercept, Focusing on Systemic Anti-vascular Endothelial Growth Factor (VEGF) Effects in Patients With neovascuLar Age-related Macular Degeneration (AMD) (UNRAVEL)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01988662 |
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Recruitment Status :
Completed
First Posted : November 20, 2013
Results First Posted : February 28, 2017
Last Update Posted : May 3, 2017
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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Brief Summary:
This study assessed systemic vascular endothelial growth factor (VEGF) level in patients with neovascular Age-related Macular Degeneration following treatment with Ranibizumab or Aflibercept.
Free plasma VEGF-A level was measured in this study .
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neovacular Age-related Macular Degeneration | Procedure: Neovascular Age-related Macular Degeneration | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 205 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official 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 |
| Study Start Date : | April 2014 |
| Actual Primary Completion Date : | September 2015 |
| Actual Study Completion Date : | September 2015 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Age-related macular degeneration
MedlinePlus related topics:
Macular Degeneration
| Arm | Intervention/treatment |
|---|---|
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Experimental: Ranibizumab
104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection adminstered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
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Procedure: Neovascular Age-related Macular Degeneration
Blood measurement
Other Name: Lucentis, Eylea |
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Active Comparator: Aflibercept
101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection admistered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
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Procedure: Neovascular Age-related Macular Degeneration
Blood measurement
Other Name: Lucentis, Eylea |
Primary Outcome Measures :
- Percent Change From Baseline at Month 3 in Plasma VEGF Following Intravitreal (IVT) Injection of Anti-VEGF Agent [ Time Frame: Change from baseline at Month 3 ]Percent change in blood VEGF level is calculated as the difference in blood VEGF level measured after 3 month of anti-VEGF agent IVT treatment (Ranibizumab or Aflibercept) when compared to baseline blood VEGF level.
Secondary Outcome Measures :
- Percent Change From Baseline in Plasma VEGF Level Overtime [ Time Frame: Change from baseline up to month 3 ]Plasma VEGF measurement performed at all visits and compared to baseline level
- Correlation Between Percent Change From Baseline Plasma VEGF Level and the Serum Anti-VEGF Agent Overtime [ Time Frame: pre-dose to post-dose at Baseline, week 1, week 2, month 1, month 2, and month 3 ]VEGF level and anti-VEGF concentration measured in the blood at each single visit, including pre- and post-dose measurement at the dosing visits.
- Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye Over Time [ Time Frame: Baseline, month 1, month 2, month 3 ]BCVA score is assessed on study eye 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. Change from baseline calculated as observed post-baseline value - baseline value.
- Mean Change From Baseline in Central Retinal Thickness (CRT) of the Study Eye Over Time [ Time Frame: Baseline, month 1, month 2, month 3 ]
CRT in micrometers assessed by Optical Tomography (OCT) at each single study visit. A reduction is thickness indicates an improvement is the lesion area.
Change from baseline calculated as observed post-baseline - baseline value.
- Number of Patients With Ocular and Systemic Adverse Events [ Time Frame: Day 1 to day 85 ]The incidence of reported treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAE).
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| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria
- Newly diagnosed Age-related Macular Degeneration (AMD)
- No previous treatment received for diagnosed AMD
- Visual Acuity 6/7.5 to 6/96
Key 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 have required anti- VEGF treatment during study period
- other disease in candidate eye which could have compromised visual acuity or required medical/surgical intervention during study period
- participation to other clinical study with 'not approved' treatment within a year prior to UNRAVEL study participation.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01988662
Locations
| Israel | |
| Novartis Investigative Site | |
| Be'er Sheva, Israel, 84101 | |
| Novartis Investigative Site | |
| Haifa, Israel, 3436212 | |
| Novartis Investigative Site | |
| Haifa, Israel, 3525408 | |
| Novartis Investigative Site | |
| Kfar-Saba, Israel, 4428164 | |
| Novartis Investigative Site | |
| Petach Tikva, Israel, 49100 | |
| Novartis Investigative Site | |
| Rehovot, Israel, 7610001 | |
| Novartis Investigative Site | |
| Tel Aviv, Israel, 6423906 | |
| Korea, Republic of | |
| Novartis Investigative Site | |
| Seoul, Korea, Korea, Republic of, 03722 | |
| Novartis Investigative Site | |
| Seoul, Korea, Korea, Republic of, 05505 | |
| Novartis Investigative Site | |
| Daegu, Korea, Republic of, 705-703 | |
| Novartis Investigative Site | |
| Seoul, Korea, Republic of, 06273 | |
| Novartis Investigative Site | |
| Seoul, Korea, Republic of, 150-950 | |
| Malaysia | |
| Novartis Investigative Site | |
| Petaling Jaya, Selangor Darul Ehsan, Malaysia, 46200 | |
| Novartis Investigative Site | |
| Kuala Lumpur, Malaysia, 59200 | |
| Philippines | |
| Novartis Investigative Site | |
| Makati City, Philippines, 1209 | |
| Novartis Investigative Site | |
| Pasig City, Philippines, 1605 | |
| Novartis Investigative Site | |
| Quezon City, Philippines, 1102 | |
| Singapore | |
| Novartis Investigative Site | |
| Singapore, Singapore, 117549 | |
| Novartis Investigative Site | |
| Singapore, Singapore, 574623 | |
| Taiwan | |
| Novartis Investigative Site | |
| Lin-Kou, Taiwan, 33305 | |
| Novartis Investigative Site | |
| Taipei, Taiwan, 10002 | |
| Thailand | |
| Novartis Investigative Site | |
| Bangkok, Bangkoknoi, Thailand, 10700 | |
| Novartis Investigative Site | |
| Bangkok, Thailand, 10330 | |
| Novartis Investigative Site | |
| Bangkok, Thailand, 10400 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01988662 |
| Other Study ID Numbers: |
CRFB002A-MAX-IL-01 2013-003482-34 ( EudraCT Number ) |
| First Posted: | November 20, 2013 Key Record Dates |
| Results First Posted: | February 28, 2017 |
| Last Update Posted: | May 3, 2017 |
| Last Verified: | March 2017 |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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nAMD, VEGF, VEGF agent, BCVA, CRT, Ranibizumab, Lucentis, Aflibercept, Eylea |
Additional relevant MeSH terms:
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Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Ranibizumab Angiogenesis Inhibitors |
Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents |