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Monoclonal Antibodies

Daclizumab for Iritis

Phase 2
Waitlist Available
Research Sponsored by National Eye Institute (NEI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights
No Placebo-Only Group

Summary

This study will examine the safety and effectiveness of a monoclonal antibody called humanized anti-Tac (HAT, also called daclizumab) to treat children and adolescents with uveitis (chronic inflammatory eye disease) associated with juvenile idiopathic arthritis (JIA). Monoclonal antibodies are genetically engineered proteins made in large quantities and directed against a specific target in the body. The HAT antibody is designed to prevent a specific chemical interaction needed for immune cells to produce inflammation. Current treatments for uveitis include steroids and immune-suppressing drugs. These treatments do not always work or they may cause significant side effects. This study will determine whether daclizumab can improve uveitis in children and reduce the need for other medicines. Patients between 6 and 18 years of age with active non-infectious JIA-associated uveitis requiring treatment with anti-inflammatory medications as often as three times a day or more may be eligible for this study. Each candidate is screened with a medical history, physical examination, blood tests, eye examination, and the following specialized tests: * Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina are taken using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating the presence of inflammation. * Optical coherence tomography to measure retinal thickness. The eyes are examined through a machine that produces cross-sectional pictures of the retina. These measures are repeated during the study to determine changes, if any, in retinal thickening. * Stereoscopic color fundus photography to examine the back of the eye. The pupils are dilated with eye drops to examine and photograph the back of the eye. Upon entering the study, participants receive a 90-minute infusion of daclizumab through a catheter (plastic tube) placed in an arm vein. They return to the clinic after 14 days and again after 28 days for repeat eye examinations, blood tests, and daclizumab infusions. Four weeks after the third infusion, patients are examined for response to treatment. Those who have benefited from daclizumab may continue receiving monthly infusions of the drug for up to one year. A blood test and eye examination are done at the time of each infusion. Patients whose disease has remained active 12 weeks after the first infusion are taken off the study and treated with other medications.

Eligible Conditions
  • Iritis
  • Juvenile Idiopathic Arthritis
  • Uveitis
  • Immunosuppression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Reporting a Serious Adverse Event (SAE)
Number of Participants With a Two-step Reduction in Inflammation

Side effects data

From 2002 Phase 4 trial • 434 Patients • NCT00048165
55%
Hypertension nos
49%
Post procedural pain
41%
Nausea
38%
Constipation
38%
Insomnia
30%
Anaemia nos
30%
Headache nos
29%
Tremor
27%
Hyperglycaemia nos
27%
Oedema lower limb
25%
Pleural effusion
24%
Diarrhoea nos
23%
Renal impairment nos
20%
Fluid overload
19%
Vomiting nos
19%
Dizziness (excl vertigo)
19%
Hypotension nos
18%
Back pain
17%
Fatigue
17%
Oedema nos
16%
Pericardial effusion
15%
Leukopenia nos
14%
Weakness
13%
Hyperkalaemia
13%
Dyspnoea nos
13%
Arthralgia
13%
Anxiety nec
12%
Pyrexia
12%
Oliguria
11%
Agitation
10%
Muscle cramps
10%
Atelectasis
10%
Upper respiratory tract infection nos
10%
Atrial fibrillation
10%
Thrombocytopenia
10%
Depression nos
10%
Pulmonary hypertension nos
9%
Nodal arrhythmia
8%
Oedema peripheral
8%
Chest pain
8%
Urinary tract infection nos
8%
Hypokalaemia
8%
Supraventricular tachycardia
8%
Rash nos
8%
Tricuspid valve incompetence
8%
Pain in limb
8%
Neutropenia
8%
Abdominal pain nos
8%
Pain nos
7%
Hypoglycaemia nos
7%
Bradycardia nos
7%
Leukocytosis
7%
Wound secretion
7%
Cough
7%
Dyspepsia
7%
Rigors
7%
Nasopharyngitis
7%
Confusion
6%
Pharyngolaryngeal pain
6%
Pneumonia nos
6%
Gout
6%
Right ventricular failure
6%
Gastrointestinal upset
6%
Hypomagnesaemia
6%
Acne nos
6%
Pressure sore
6%
Hypervolaemia
6%
Weight increased
6%
Hypoaesthesia
6%
Pneumothorax nos
6%
Paraesthesia
6%
Abdominal distension
6%
Liver function tests nos abnormal
5%
Pericardial rub
5%
Arrhythmia nos
5%
Hiccups
5%
Tachycardia nos
5%
Ventricular hypokinesia
5%
Ventricular tachycardia
5%
Hyperlipidaemia nos
5%
Metabolic acidosis nos
5%
Myalgia
4%
Peripheral swelling
4%
Dysuria
3%
Sepsis nos
3%
Diabetes mellitus nos
3%
Wound infection nec
3%
Cardiac arrest
3%
Bronchitis nos
2%
Productive cough
2%
Basal cell carcinoma
2%
Convulsions nos
2%
Hyponatraemia
2%
Abdominal pain upper
1%
Respiratory failure (excl neonatal)
1%
Intracranial haemorrhage nos
1%
Injection site infection
1%
Respiratory distress
1%
Colonic perforation
1%
Cellulitis
1%
Viral infection nos
1%
Aortic injury
1%
Post procedural haemorrhage
1%
Abscess nos
1%
Anoxic encephalopathy
1%
Atrial flutter
1%
Cardiac tamponade
1%
Cardiogenic shock
1%
Septic shock
1%
Wound dehiscence
1%
Encephalopathy nos
1%
Renal failure acute
1%
Renal failure nos
1%
Mediastinitis
1%
Breath sounds decreased
1%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Daclizumab
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: DaclizumabExperimental Treatment1 Intervention
IV daclizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daclizumab
Not yet FDA approved

Find a Location

Who is running the clinical trial?

National Eye Institute (NEI)Lead Sponsor
553 Previous Clinical Trials
1,407,303 Total Patients Enrolled
2 Trials studying Iritis
3,300 Patients Enrolled for Iritis
The Emmes Company, LLCIndustry Sponsor
147 Previous Clinical Trials
1,052,154 Total Patients Enrolled
~0 spots leftby Nov 2025