NCT00820014

Brief Summary

The purpose of this study is to determine whether ESBA105, a single-chain (scFv) antibody against TNF-alpha, efficiently penetrates into the anterior chamber and the vitreous body upon topical administration to the eye.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

January 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

September 24, 2010

Status Verified

January 1, 2009

Enrollment Period

1.7 years

First QC Date

January 8, 2009

Last Update Submit

September 23, 2010

Conditions

Cataract

Keywords

ESBA105scFv antibody fragmentcataract surgerypharmacokineticsbiodistributionIrvine-Gass syndrome

Outcome Measures

Primary Outcomes (1)

  • Determination of intraocular ESBA105 levels, local biodistribution (aqueous and vitreous humor) and intraocular pharmacokinetics upon topical administration.

    Collection of respective biological matrices at occasion of ocular surgery

Secondary Outcomes (3)

  • Exploratory assessment of the anti-inflammatory potential of prophylactic, topical ESBA105 for prevention of post-surgical inflammation following cataract surgery.

    10 Days following ocular surgery

  • Assessment of local tolerability and safety of topical ESBA105.

    up to 10 Days following ocular surgery

  • Assessment of systemic exposure upon topical application of ESBA105.

    1 Day following ocular surgery

Study Arms (2)

1

EXPERIMENTAL

ESBA105 eye drops

Drug: Placebo

2

PLACEBO COMPARATOR

Placebo control (vehicle)

Drug: Placebo

Interventions

PlaceboDRUG

Placebo control (vehicle) eye drops applied 4-times a day for 4 days before ocular surgery

12

Eligibility Criteria

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

You may qualify if:

  • Male or female Caucasian patients ≥18 years.
  • Written informed consent prior to any study procedures including screening tests for eligibility.
  • Patients should be in good health as determined by past medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory tests at screening.
  • Ability to administer eye drops (personally or administered by another person).
  • Cataract patients:
  • Eligible for routine, uncomplicated senile cataract surgery.
  • Vitrectomy patients:
  • Diagnosis of epiretinal fibroplasia requiring vitrectomy and cataract surgery.

You may not qualify if:

  • Treated glaucoma / elevated intraocular pressure (IOP) requiring therapy.
  • History of chronic or recurrent intraocular inflammatory disease.
  • Uncontrolled diabetes mellitus (fasting blood glucose \>15 mmol/L).
  • Diabetic retinopathy with history of laser photocoagulation.
  • Patients with a single eye or a pinholed visual acuity (VA) 20/200 or worse measured on Snellen chart in the non-study eye.
  • Iris atrophy in the eye to undergo surgery.
  • Pregnant or breast-feeding women or women of childbearing potential, who with their partners refuse to use 2 reliable methods of contraception
  • History of collagenosis or systemic vasculitis.
  • Patients who have had ocular surgery (including laser surgery) in the study eye within 3 months or in the contralateral eye within 2 weeks prior to screening.
  • Patients who have an active systemic or local (anywhere in the body) bacterial and/or viral infection.
  • Positive or unclear QuantiFERON-TB Gold assay result.
  • Participation in a clinical study with investigational drugs within 3 months prior to screening.
  • Inability to comply with the study requirements.
  • Patients with known, severely impaired hepatic function, or laboratory values reflecting inadequate hepatic function.
  • Patients with pre-existing chronic renal failure defined by a calculated creatinine clearance (CrCl) of \< 40 mL/min, using the Cockcroft-Gault estimate for glomerular filtration rate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kantonsspital Luzern, Augenklinik, CH-6000 Luzern 16, Switzerland

Lucerne, Canton of Lucerne, 6000, Switzerland

Location

Pallas Gruppe

Olten, Canton of Solothurn, 4600, Switzerland

Location

MeSH Terms

Conditions

CataractMacular Edema

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesMacular DegenerationRetinal DegenerationRetinal Diseases

Study Officials

  • Michael A Thiel, MD, PhD

    Kantonsspital Luzern, Augenklinik, CH-6000 Luzern 16, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 8, 2009

First Posted

January 9, 2009

Study Start

January 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

September 24, 2010

Record last verified: 2009-01

Locations

CH(2)