CataractPhase 1/2NCT00820014
Ocular Biodistribution Study for Topically Applied ESBA105
A Phase 1/2 study of Cataract, run by ESBATech AG at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Jan 2009to Sep 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Kantonsspital Luzern, Augenklinik, CH-6000 Luzern 16, Switzerland
Lucerne, Canton of Lucerne, 6000
Pallas Gruppe
Olten, Canton of Solothurn, 4600
About this study
Official title: Evaluation of Tolerability, Safety and Ocular Pharmacokinetics of Topically Applied ESBA105 in Patients Undergoing Cataract Surgery or Combined Cataract Surgery and Vitrectomy
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.
Read the detailed description
ESBA105 is a topically administered tumour necrosis factor alpha (TNF-alpha) inhibitor that has significant therapeutic potential in various inflammatory intraocular diseases. In animal experiments, ESBA105 was shown to efficiently penetrate into the inner of the eye upon topical administration, associated with very low systemic exposure. A recently completed Phase I trial with topical ESBA105 has confirmed the safety of topical administration to the human eye and the low systemic exposure using this route of administration.
This study is designed to determine the intraocular levels and the specific intraocular distribution pattern of ESBA105 following topical administration to the human eye. In addition it shall be explored whether topical administration of ESBA105 reduces intraocular inflammation following cataract surgery.
Three different dose regimens will be applied to four different patient cohorts. Three patient cohorts will be conducted in an open label design and one in a double-masked, placebo controlled design.
- Conditions
- Cataract
- Being tested
- Placebo
- Keywords
- ESBA105, scFv antibody fragment, cataract surgery, pharmacokinetics, biodistribution, Irvine-Gass syndrome
- Medical subject headings
- Cataract, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo control (vehicle) eye drops applied 4-times a day for 4 days before ocular surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ESBA105 eye drops Receives: Drug: Placebo |
| 2 | Placebo comparator | Placebo control (vehicle) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of intraocular ESBA105 levels, local biodistribution (aqueous and vitreous humor) and intraocular pharmacokinetics upon topical administration.
Measured: 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.
Measured: 10 Days following ocular surgery
Assessment of local tolerability and safety of topical ESBA105.
Measured: up to 10 Days following ocular surgery
Assessment of systemic exposure upon topical application of ESBA105.
Measured: 1 Day following ocular surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- ESBATech AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael A Thiel, MD, PhD, Principal investigator, Kantonsspital Luzern, Augenklinik, CH-6000 Luzern 16, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820014
- Sponsor's protocol ID
- ESBA105CRD03
- Status last verified
- Jan 2009
- First submitted
- 8 Jan 2009
- Last updated
- 24 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tolerability, Safety and Ocular Pharmacokinetics of Topically Applied ESBA105 in Patients Undergoing Cataract Surgery or Combined Cataract Surgery and Vitrectomy
- ClinicalTrials.gov ID
- NCT00820014
- Acronym / sponsor ID
- ESBA105CRD03
- Conditions
- Cataract
- Keywords
- ESBA105, scFv antibody fragment, cataract surgery, pharmacokinetics, biodistribution, Irvine-Gass syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- ESBATech AGIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 9 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
ESBA105 is a topically administered tumour necrosis factor alpha (TNF-alpha) inhibitor that has significant therapeutic potential in various inflammatory intraocular diseases. In animal experiments, ESBA105 was shown to efficiently penetrate into the inner of the eye upon topical administration, associated with very low systemic exposure. A recently completed Phase I trial with topical ESBA105 has confirmed the safety of topical administration to the human eye and the low systemic exposure using this route of administration.
This study is designed to determine the intraocular levels and the specific intraocular distribution pattern of ESBA105 following topical administration to the human eye. In addition it shall be explored whether topical administration of ESBA105 reduces intraocular inflammation following cataract surgery.
Three different dose regimens will be applied to four different patient cohorts. Three patient cohorts will be conducted in an open label design and one in a double-masked, placebo controlled design.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PlaceboESBA105 eye drops |
| 2 | Placebo comparator | Drug: PlaceboPlacebo control (vehicle) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
- Eligible for routine, uncomplicated senile cataract surgery.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo control (vehicle) eye drops applied 4-times a day for 4 days before ocular surgery | Drug | 1, 2 |
Primary outcome
Determination of intraocular ESBA105 levels, local biodistribution (aqueous and vitreous humor) and intraocular pharmacokinetics upon topical administration.
Time frame: Collection of respective biological matrices at occasion of ocular surgery
3 secondary outcomes
Exploratory assessment of the anti-inflammatory potential of prophylactic, topical ESBA105 for prevention of post-surgical inflammation following cataract surgery.
Time frame: 10 Days following ocular surgery
Assessment of local tolerability and safety of topical ESBA105.
Time frame: up to 10 Days following ocular surgery
Assessment of systemic exposure upon topical application of ESBA105.
Time frame: 1 Day following ocular surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A Thiel, MD, PhD principal investigator
Kantonsspital Luzern, Augenklinik, CH-6000 Luzern 16, Switzerland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study of Cataract, run by ESBATech AG at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of intraocular ESBA105 levels, local biodistribution (aqueous and vitreous humor) and intraocular pharmacokinetics upon topical administration. (time frame: Collection of respective biological matrices at occasion of ocular surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2010.