Clinical trial NCT01988662: 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)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neovacular Age-related Macular Degeneration
Keywords: nAMD, VEGF, VEGF agent, BCVA, CRT, Ranibizumab, Lucentis, Aflibercept, Eylea
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-11-20
Enrollment: 205
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .


Eligibility 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.

Primary outcomes:
measure: Percent Change From Baseline at Month 3 in Plasma VEGF Following Intravitreal (IVT) Injection of Anti-VEGF Agent
timeFrame: Change from baseline at Month 3
Secondary outcomes:
measure: Percent Change From Baseline in Plasma VEGF Level Overtime
timeFrame: Change from baseline up to month 3
measure: Correlation Between Percent Change From Baseline Plasma VEGF Level and the Serum Anti-VEGF Agent Overtime
timeFrame: pre-dose to post-dose at Baseline, week 1, week 2, month 1, month 2, and month 3
measure: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye Over Time
timeFrame: Baseline, month 1, month 2, month 3
measure: Mean Change From Baseline in Central Retinal Thickness (CRT) of the Study Eye Over Time
timeFrame: Baseline, month 1, month 2, month 3
measure: Number of Patients With Ocular and Systemic Adverse Events
timeFrame: Day 1 to day 85
Other outcomes:
Locations:
city: Be'er Sheva
country: Israel
facility: Novartis Investigative Site
city: Haifa
country: Israel
facility: Novartis Investigative Site
city: Haifa
country: Israel
facility: Novartis Investigative Site
city: Kfar-Saba
country: Israel
facility: Novartis Investigative Site
city: Petach Tikva
country: Israel
facility: Novartis Investigative Site
city: Rehovot
country: Israel
facility: Novartis Investigative Site
city: Tel Aviv
country: Israel
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Daegu
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Petaling Jaya
country: Malaysia
facility: Novartis Investigative Site
state: Selangor Darul Ehsan
city: Kuala Lumpur
country: Malaysia
facility: Novartis Investigative Site
city: Makati City
country: Philippines
facility: Novartis Investigative Site
city: Pasig City
country: Philippines
facility: Novartis Investigative Site
city: Quezon City
country: Philippines
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Lin-Kou
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
state: Bangkoknoi
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: