Health TrialsbyHealthPanel

Intravitreal Adalimumab Versus Subcutaneous Adalimumab in Non-infectious Uveitis

ConditionsUveitisNon-Infectious Uveitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAmerican University of Beirut Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject is ≥ 18 years of age.

Subject is diagnosed with non-infectious intermediate-, posterior-, or pan-uveitis.

Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion

≥ 1+ anterior chamber cells (Standardization of Uveitis Nomenclature [SUN] criteria)

Disqualifiers

Subject with isolated anterior uveitis.

Subject with confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, cytomegalovirus, lyme disease, toxoplasmosis and herpes simplex virus (HSV).

Subject with serpiginous choroidopathy.

Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adalimumab

    Drug

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: IntravitrealActive comparator 1 intervention
Group B: SystemicActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Vitreous Haze

Change in Vitreous Haze grade in each eye \[National Eye Institute (NEI)/ Standardization of Uveitis Nomenclature (SUN) criteria\]

Time frame
26 Weeks
2

Anterior Chamber Cells

Change in Anterior Chamber (AC) cell grade in each eye.

Time frame
26 Weeks

Secondary outcomes

1

Visual Acuity

Change in ETDRS letters and logarithm of the minimum angle of resolution (log MAR) best-corrected visual acuity (BCVA) in each eye.

Time frame
26 Weeks
2

Macular Edema

Change in central retinal thickness on Optical Coherence Tomography (OCT).

Time frame
26 Weeks
3

Angiography Score

Change in fluorescein angiography score

Time frame
26 Weeks
4

Steroids Tapering

If the patient is initially on steroids (pre-enrolment); Success in tapering steroid dose as a response to the protocol.

Time frame
26 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

American University of Beirut Medical Center

Lead sponsor

Source ClinicalTrials.gov
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