Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00846625
Other study ID # 34035
Secondary ID
Status Withdrawn
Phase Phase 2
First received February 18, 2009
Last updated December 9, 2014
Start date November 2009
Est. completion date August 2011

Study information

Verified date December 2014
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This is a pilot study to investigate the safety and efficacy of intravitreally administered ranibizumab (Lucentis) compared to steroid injection for the treatment of macular edema due to chronic non-infectious uveitis. There is currently no FDA-approved therapy for this condition, however intravitreal injection of corticosteroids, in conjunction with oral steroids and/or immunomodulatory drug agents, has become the mainstay of therapy. Ranibizumab is a recombinant monoclonal antibody antigen-binding fragment that neutralizes the active forms of vascular endothelial growth factor (VEGF), which is believed to contribute to the etiology of inflammation and neovascularization. Ranibizumab is FDA-approved for the treatment of neovascular age-related macular degeneration.


Description:

This is a proof of concept study to assess the safety and potential efficacy of ranibizumab in this patient population. Since it is common clinical practice to perform regional periocular injections of steroids in patients with uveitic macular edema, only patients who are refractory to periocular steroids will be enrolled in the study. The 0.5 mg dose of ranibizumab will be given intravitreally since this dose and route has been found to be safe and efficacious in prior studies. A dosing regimen has not been established for ranibizumab in patients with uveitis, so patients will be assessed and treated monthly as needed. Triamcinolone 4mg intravitreal injection will be the steroid treatment, and patients will also be assessed monthly and retreated every three months as needed.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- At least 18 years of age

- History of non-infectious uveitis w chronic cystoid macular edema

- Refractory to therapy w periocular steroids; Last periocular steroid injection a minimum of 3 months prior to study enrollment

- Currently using oral steroids (< or = 10 mg/day) and/or steroid sparing agents

- BCVA between 20/40 and 20/400

- IOP between 5 mmHg and 30 mmHg

- Media clarity sufficient for OCT measurement

Exclusion Criteria:

- Women known to be pregnant or have a positive urine pregnancy test; Pre-menopausal women not using adequate contraception during the study

- Prior treatment for CME with Macugen or Avastin in the study eye

- History of stroke

- Presence of vitreous hemorrhage or epiretinal membrane in the study eye

- Active infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye

- Presence or history of uncontrolled glaucoma

- Known allergy or hypersensitivity to any component of the study drug

- Major surgery planned during the next 6 months

- Simultaneous participation in another clinical investigation

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
triamcinolone
Intravitreal injection (4 mg/0.1 ml)
ranibizumab
Intravitreal injection, 0.5 mg

Locations

Country Name City State
United States John Moran Eye Center Salt Lake City Utah

Sponsors (2)

Lead Sponsor Collaborator
University of Utah Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ocular adverse events 12 months Yes
Secondary Resolution of macular edema by OCT measurement 3, 6 and 12 months No
See also
  Status Clinical Trial Phase
Completed NCT04292912 - A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2798745 in Participants With Diabetic Macular Edema Phase 1
Recruiting NCT05976139 - Micropulsed Laser in Patients With Macular Oedema in Retinal Dystrophies N/A
Completed NCT03660345 - PPV With Internal Limiting Membrane Peeling for Treatment-Naïve DME Phase 3
Completed NCT03660371 - ILM Peeling in PDR Patients Undergoing PPV for VH N/A
Completed NCT01660802 - Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO) Phase 3
Completed NCT01908816 - An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases. Phase 3
Completed NCT04592419 - A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO) Phase 3
Completed NCT02867735 - A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema Phase 1
Completed NCT02623673 - Simultaneous Therapy With Intravitreal Dexamethasone Implant and Bevacizumab for the Treatment of Macular Edema N/A
Terminated NCT01946399 - Ozurdex Implant for Macular Edema After Treatment Failure With Anti-VEGF N/A
Completed NCT01428388 - Bevacizumab Versus Ranibizumab in Treatment of Macular Edema From Vein Occlusion N/A
Completed NCT01231633 - Comparison of Initial Ozurdex (Dexamethasone Implant) to Avastin (Bevacizumab) for Treatment of Macular Edema Caused by Central Retinal Vein Occlusion (CRVO) N/A
Recruiting NCT01023113 - To Compare Visual Field Impairment in Conventional Double Frequency Nd: YAG Panretinal Photocoagulation With PASCAL Panretinal Photocoagulation N/A
Terminated NCT00969293 - Study to Assess the Safety and Tolerability of a Single Administration of FOV2302 (Ecallantide) in Patients With Macular Edema Associated With Central Retinal Vein Occlusion Phase 1
Terminated NCT00918554 - Efficacy Study of Methotrexate to Treat Sarcoid-associated Uveitis Phase 4
Completed NCT00970957 - Safety and Effectiveness of Bevacizumab Intravitreal Injections in the Treatment of Macular Edema Secondary to Retinal Vein Occlusion Phase 3
Completed NCT00476593 - Retinal OCT and (mfERG) Related to Age, Sex, and the Use of Anti-inflammatory Medications N/A
Completed NCT00668239 - Diffuse Diabetic Maculopathy With Intravitreal Triamcinolone or Laser N/A
Completed NCT00411970 - 20- Versus 23- Gauge System for Pars Plana Vitrectomy Phase 4
Terminated NCT01939691 - Macular Edema Nepafenac vs. Difluprednate Uveitis Trial Phase 4