NCT01905124

Brief Summary

This is a Phase 2, randomized, double-masked, placebo-controlled study subjects with active, sight-threatening, noninfectious intermediate or posterior uveitis.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 23, 2013

Completed
5.4 years until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

February 1, 2018

Status Verified

January 1, 2018

Enrollment Period

8 months

First QC Date

July 14, 2013

Last Update Submit

January 30, 2018

Conditions

Uveitis, PosteriorUveitis, Intermediate

Keywords

UveitisIntermediate uveitisPosterior uveitis

Outcome Measures

Primary Outcomes (1)

  • Severity of uveitis on standardized photographic assessment

    Standardized fundus photographs will be obtained and uniformly assessed in a masked fashion at the Reading Center

    24 weeks

Secondary Outcomes (1)

  • Safety of CF101

    24 weeks

Study Arms (2)

Drug: CF101

EXPERIMENTAL

CF101 1 mg q12 hours

Drug: CF101

Placebo tablets of CF101

PLACEBO COMPARATOR

Placebo tablets q12 hours

Drug: Placebo

Interventions

CF101DRUG

CF101 1 mg tablets orally every 12 hours for 24 weeks

Also known as: IB-MECA
Drug: CF101
PlaceboDRUG

Matching placebo tablets orally every 12 hours for 24 weeks

Also known as: Sugar pills
Placebo tablets of CF101

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, 18 years of age and over;
  • Diagnosis of active, sight-threatening, noninfectious intermediate or posterior uveitis, as determined by the Standardization of Uveitis Nomenclature (SUN) Working Group Criteria.
  • Vitreous haze in at least 1 eye (the "study eye") of ≥Grade 3 on the "Miami Scale" at the Screening Visit, as confirmed by the Uveitis Photograph Reading Center; ,
  • Best corrected visual acuity (BCVA) in the poorer seeing eye of 1.3 logarithm of the minimum angle of resolution (logMAR) or better by Early Treatment Diabetic Retinopathy Study (ETDRS; equivalent to 20/400) at Screening;
  • Requires, in the judgment of the Investigator, systemic therapy to treat uveitis;
  • No plans for elective ocular surgery during the trial duration;
  • \. Ability to understand and provide written informed consent.

You may not qualify if:

  • Primary diagnosis of anterior uveitis;
  • Uveitis of infectious etiology;
  • Presence of chorioretinal scars that are highly suspicious for ocular toxoplasmosis;
  • Confirmed or suspected uveitis of traumatic etiology;
  • Clinically suspected or confirmed central nervous system or ocular lymphoma;
  • Presence of any other form of ocular malignancy in the either eye including choroidal melanoma;
  • Corneal or lens opacities or obscured ocular media other than vitreous haze upon enrollment such that reliable clinical evaluations and grading of the posterior segment cannot be performed;
  • Pupillary dilation inadequate for quality fundus photography;
  • Uncontrolled glaucoma or ocular hypertension in either eye, defined as intraocular pressure (IOP) \>21 mm Hg while on medical therapy;
  • Chronic hypotony (IOP \<6 mm Hg) in either eye;
  • Presence of an ocular implantable steroid-eluting device;
  • Ocular injection of corticosteroid within 3 months prior to Baseline;
  • Use of Retisert within 6 months prior to baseline;
  • Use of the following within 90 days prior to Baseline or anticipated use to either eye during the trial:
  • Intravitreal injections (including but not limited to steroids or anti-vascular endothelial growth factors), or
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bnei-Zion Medical Center

Haifa, 31048, Israel

Location

MeSH Terms

Conditions

Uveitis, PosteriorUveitis, IntermediateUveitis

Interventions

CF101N(6)-(3-iodobenzyl)-5'-N-methylcarboxamidoadenosine

Condition Hierarchy (Ancestors)

PanuveitisUveal DiseasesEye Diseases
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2013

First Posted

July 23, 2013

Study Start

January 1, 2019

Primary Completion

September 1, 2019

Study Completion

October 1, 2019

Last Updated

February 1, 2018

Record last verified: 2018-01

Locations

IL(1)