Macular DegenerationPhase 1NCT00414999
A Phase 1 Safety Study of TG100801 Eye Drops in Healthy Volunteers
A Phase 1 study testing TG100801 in people with Macular Degeneration and Diabetic Retinopathy, run by TargeGen at 1 site in United States.
Trial summary
The formation of new blood vessels (angiogenesis), blood vessel leakage, and inflammation contribute to the progression of the eye disease, age-related macular degeneration (AMD), which is the leading cause of irreversible, severe loss of vision in people 55 years of age and older in the developed world. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Macular Degeneration, Diabetic Retinopathy
- What is being tested?
- TG100801
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Feb 2007
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female healthy volunteers who meet the following criteria are eligible for inclusion in the study. Subjects who participate in Part A of the study may not participate in Part B.
- Age > 18 years (50% of subjects must be > 40 years of age).
- Corrected visual acuity > 20/25 in both eyes.
- Intraocular pressure (IOP) < 21 mm Hg, with a difference between eyes of < 4 mm Hg.
- Ability to tolerate and self-administer vehicle eye drops to the satisfaction of study staff.
- Tolerance of a commercially available benzalkonium chloride-preserved, artificial tear solution in one eye.
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- Normal slit lamp exam and dilated fundoscopic exam within 2 weeks of dosing.
- Normal clinical laboratory profiles, defined as complete blood count, serum chemistry, and urinalysis values within the normal range.
- Willing to abstain from the concomitant use of ocular or systemic medication (excluding acetaminophen and multivitamins) from 2 weeks prior to start of study dosing until study completion.
- Willing to comply with scheduled visits, treatment plans, laboratory assessments, and other study-related procedures.
- Provide written informed consent to participate.
Who cannot join
- Subjects who meet any of the following criteria are excluded from the study:
- History of ocular surgery, trauma, or chronic ocular disease.
- Current use of contact lenses or discontinuation of contact lens use within 2 weeks of the first dosing day.
- Any ocular abnormalities or ocular symptoms (defined as a non-zero score on assessment scales).
- Use of ocular agents (including eye drops) within the past 2 months or anticipated use of ocular agents during the study period.
- Systemic corticosteroid use within the past 6 months.
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- History or evidence of ocular infection, inflammation, blepharitis, or conjunctivitis with 2 months; history of herpes simplex keratitis.
- Presence of a nonhealing wound, ulcer, fracture, or any medical condition associated with bleeding.
- Use of antimitotic or antimetabolite therapy within 2 months of enrollment.
- Loss, donation, or removal of 400 mL or more of blood within the past 2 months.
- Women who are pregnant or breastfeeding, or nonsterile or premenopausal women who refuse to use two proven methods of contraception during and for at least 2 weeks following the final dose of study drug.
- Enrollment in another investigational drug or device study within 2 months of study entry.
- Ongoing cardiac arrhythmias or prolongation of the QTc interval to > 450 msec for males or > 470 msec for females.
- Known liver, kidney, cardiovascular, neurologic, or pulmonary disease; treated or untreated hypertension; current or history of drug or alcohol abuse.
- Known human immunodeficiency virus- or acquired immunodeficiency syndrome-related illness.
- Known intolerance to any excipients in the study drug formulation.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, would affect the subject's ability to follow study-related procedures, or may interfere with the interpretation of study results and, in the investigator's opinion, would make the patient inappropriate for entry into this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Quintiles Phase One Services, Inc.
Lenexa, Kansas, 66219
About this study
Official title: A Phase 1, Double-Masked, Placebo-Controlled, Dose-Escalation Study (in Two Parts) of TG100801 and a Colored Vehicle in Adult Healthy Volunteers
The formation of new blood vessels (angiogenesis), blood vessel leakage, and inflammation contribute to the progression of the eye disease, age-related macular degeneration (AMD), which is the leading cause of irreversible, severe loss of vision in people 55 years of age and older in the developed world. TG100801 is a new drug that inhibits ocular angiogenesis, vascular leak, and inflammation in laboratory studies, and may have great utility in the treatment of diseases such as AMD.
The purpose of this study is to assess the safety, ocular tolerability, and blood pharmacokinetics of TG100801 at escalating doses in healthy volunteers.
- Conditions
- Macular Degeneration, Diabetic Retinopathy
- Being tested
- TG100801
- Keywords
- Macular degeneration, Vascular diseases, Retinal disorders, Macular edema
- Medical subject headings
- Macular Degeneration, Diabetic Retinopathy, Vascular Diseases, Retinal Diseases, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TG100801Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Safety & tolerability of vehicle & 2 concentrations of TG100801 (ophthalmic examinations, ocular comfort ratings, ocular/systemic adverse events, lab tests) when administered twice a day for 1 day, assessed up to 5 (+/- 1) days following dosing.
Part B: Safety & tolerability of 2 concentrations of TG100801 (ophthalmic examinations, ocular comfort ratings, ocular/systemic adverse events, lab tests) when administered twice a day for 14 days, assessed up to 7-14 days following dosing.
Secondary outcomes (1)
Systemic pharmacokinetics (Part B only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2006 (estimated)
- Study startNov 2006
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- TargeGen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Philip T Leese, M.D., Principal investigator, Quintiles Phase One Services, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414999
- Sponsor's protocol ID
- OPH-TG100801-001
- Status last verified
- Jul 2007
- First submitted
- 20 Dec 2006
- Last updated
- 30 Jul 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Masked, Placebo-Controlled, Dose-Escalation Study (in Two Parts) of TG100801 and a Colored Vehicle in Adult Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00414999
- Acronym / sponsor ID
- OPH-TG100801-001
- Conditions
- Macular Degeneration, Diabetic Retinopathy
- Keywords
- Macular degeneration, Vascular diseases, Retinal disorders, Macular edema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- TargeGenIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Study completion
- Feb 2007 (actual)
- First posted
- 22 Dec 2006 (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 formation of new blood vessels (angiogenesis), blood vessel leakage, and inflammation contribute to the progression of the eye disease, age-related macular degeneration (AMD), which is the leading cause of irreversible, severe loss of vision in people 55 years of age and older in the developed world. TG100801 is a new drug that inhibits ocular angiogenesis, vascular leak, and inflammation in laboratory studies, and may have great utility in the treatment of diseases such as AMD.
The purpose of this study is to assess the safety, ocular tolerability, and blood pharmacokinetics of TG100801 at escalating doses in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female healthy volunteers who meet the following criteria are eligible for inclusion in the study. Subjects who participate in Part A of the study may not participate in Part B.
- Age > 18 years (50% of subjects must be > 40 years of age).
- Corrected visual acuity > 20/25 in both eyes.
- Intraocular pressure (IOP) < 21 mm Hg, with a difference between eyes of < 4 mm Hg.
- Ability to tolerate and self-administer vehicle eye drops to the satisfaction of study staff.
Key exclusion criteria (17 listed)
- History of ocular surgery, trauma, or chronic ocular disease.
- Current use of contact lenses or discontinuation of contact lens use within 2 weeks of the first dosing day.
- Any ocular abnormalities or ocular symptoms (defined as a non-zero score on assessment scales).
- Use of ocular agents (including eye drops) within the past 2 months or anticipated use of ocular agents during the study period.
- Systemic corticosteroid use within the past 6 months.
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 |
|---|---|---|
| TG100801 | Drug | – |
Primary outcome
Part A: Safety & tolerability of vehicle & 2 concentrations of TG100801 (ophthalmic examinations, ocular comfort ratings, ocular/systemic adverse events, lab tests) when administered twice a day for 1 day, assessed up to 5 (+/- 1) days following dosing.
Part B: Safety & tolerability of 2 concentrations of TG100801 (ophthalmic examinations, ocular comfort ratings, ocular/systemic adverse events, lab tests) when administered twice a day for 14 days, assessed up to 7-14 days following dosing.
1 secondary outcome
Systemic pharmacokinetics (Part B only)
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 30 Jul 2007.
- American Macular Degeneration FoundationLink provided by the sponsor.
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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.
Philip T Leese, M.D. principal investigator
Quintiles Phase One Services, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TG100801 in people with Macular Degeneration and Diabetic Retinopathy, run by TargeGen at 1 site in United States.
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 11 inclusion and 17 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 30 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
Part A: Safety & tolerability of vehicle & 2 concentrations of TG100801 (ophthalmic examinations, ocular comfort ratings, ocular/systemic adverse events, lab tests) when administered twice a day for 1 day, assessed up to 5 (+/- 1) days following dosing.. The study lists 2 primary outcomes in all. 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 30 Jul 2007.