Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2026-01-25 @ 9:37 AM
Study NCT ID:
NCT02706704
Status:
RECRUITING
Last Update Posted:
2025-02-26
First Post:
2016-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravitreal Adalimumab Versus Subcutaneous Adalimumab in Non-infectious Uveitis
Sponsor:
American University of Beirut Medical Center
Organization:
Study Overview
Official Title:
Efficacy of Intravitreal Adalimumab Compared to Subcutaneous Adalimumab in Patients With Non-infectious Uveitis
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IVAS
Brief Summary:
The objective of this study is to compare and evaluate the efficacy of subcutaneous (40mg) adalimumab biweekly injections to intravitreal adalimumab (1.5 mg/ 0.03 mL) administration, given at zero, 2 weeks then every four weeks, in subjects with active non-infectious intermediate-, posterior-, or pan-uveitis.
Detailed Description:
Subject groups:
32 subjects will be enrolled in this study, 16 in each arm. They will be randomized to receive either 1.5 mg/ 0.03 mL of adalimumab by intravitreal injection or 40 mg of adalimumab subcutaneously at their first treatment visit and at the 2 weeks visit if eligible for a repeat injection. Follow up will be every 2 days the first week then one week later and after that every 4-week intervals for total of 26 weeks.
Intervention Details:
* Systemic adalimumab: Subcutaneous injection of 40 mg adalimumab (Humira) given every 2 weeks.
* Local adalimumab: Intravitreal injection of 1.5mg/0.03ml adalimumab given at zero, 2 weeks, and then every 4 weeks.
Pre-treatment work up
Patients will undergo a comprehensive eye exam:
* Visual acuity, slit-lamp examination of the anterior segment, dilated fundus examination, electroretinography (ERG) and fluorescein angiography (FA).
* Central macular thickness of all eyes will be measured with ocular coherence tomography before treatment.
* Purified Protein Derivative (PPD), Complete blood count (CBC) and SGPT.
Post-injection follow-up
* Patients will be followed up every 2 days during the first week then one week later and after that every 4-week intervals.
* On follow up visits, if deterioration in vision of two or more ETDRS lines or worsening of ocular inflammation by more than 1+ cells/haze is detected at any visit, patients will be removed from the study and receive appropriate treatment. Otherwise, if vision was stable or improved and/or inflammation is same or better, patients will be re-injected.
* Follow up is for 26 weeks.
* OCT and fluorescein angiography each visit.
* ERG will be performed at baseline and 26 weeks.
* Blood studies (CBC and SGPT) will be performed at baseline, 14 weeks and at 26 weeks.
* Injections would be delayed if a patient has an acute infection and would be given when it subsides.
32 subjects will be enrolled in this study, 16 in each arm. They will be randomized to receive either 1.5 mg/ 0.03 mL of adalimumab by intravitreal injection or 40 mg of adalimumab subcutaneously at their first treatment visit and at the 2 weeks visit if eligible for a repeat injection. Follow up will be every 2 days the first week then one week later and after that every 4-week intervals for total of 26 weeks.
Intervention Details:
* Systemic adalimumab: Subcutaneous injection of 40 mg adalimumab (Humira) given every 2 weeks.
* Local adalimumab: Intravitreal injection of 1.5mg/0.03ml adalimumab given at zero, 2 weeks, and then every 4 weeks.
Pre-treatment work up
Patients will undergo a comprehensive eye exam:
* Visual acuity, slit-lamp examination of the anterior segment, dilated fundus examination, electroretinography (ERG) and fluorescein angiography (FA).
* Central macular thickness of all eyes will be measured with ocular coherence tomography before treatment.
* Purified Protein Derivative (PPD), Complete blood count (CBC) and SGPT.
Post-injection follow-up
* Patients will be followed up every 2 days during the first week then one week later and after that every 4-week intervals.
* On follow up visits, if deterioration in vision of two or more ETDRS lines or worsening of ocular inflammation by more than 1+ cells/haze is detected at any visit, patients will be removed from the study and receive appropriate treatment. Otherwise, if vision was stable or improved and/or inflammation is same or better, patients will be re-injected.
* Follow up is for 26 weeks.
* OCT and fluorescein angiography each visit.
* ERG will be performed at baseline and 26 weeks.
* Blood studies (CBC and SGPT) will be performed at baseline, 14 weeks and at 26 weeks.
* Injections would be delayed if a patient has an acute infection and would be given when it subsides.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: