TransplantNCT00884039
Anecortave Acetate Injection to Treat Steroid-responsive Intraocular Pressure Increase in Cornea Transplant Patients
A study testing anecortave acetate and 30 mg anecortave acetate in people with Transplant and Intraocular Pressure, run by Cornea Research Foundation of America at 1 site in United States.
Trial summary
This study will investigate the use of anecortave acetate injection to reduce intraocular pressure (IOP) in corneal transplant recipients who are experiencing steroid-associated pressure control problems. Alternative methods of IOP control have been shown to entail serious risks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplant, Intraocular Pressure
- What is being tested?
- anecortave acetate and 30 mg anecortave acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Sep 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- at least 18 years of age
- corneal transplant recipient with intraocular pressure (IOP) greater than 24 mmHg and with relative increase in IOP of at least 10 mmHg over the pre-graft baseline
Who cannot join
- not pregnant or lactating
- intraocular surgery in the study eye within 30 days before enrolling in the study
- use of any investigational drug or treatment within 30 days before receipt of study medication
- clinical evidence of scleral thinning
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compassionate Use of Anecortave Acetate: Clinical Protocol for the Treatment of Corticosteroid-induced Intraocular Pressure (IOP) Increases After Corneal Transplantation
This study will investigate the use of anecortave acetate injection to reduce intraocular pressure (IOP) in corneal transplant recipients who are experiencing steroid-associated pressure control problems. Alternative methods of IOP control have been shown to entail serious risks. For example, reduction of topical steroids increases the risk of graft rejection, and use of glaucoma medications or glaucoma surgery increases the risk of graft failure. This study is designed to have sufficient power to detect whether a single injection can induce a clinically significant IOP reduction.
- Conditions
- Transplant, Intraocular Pressure
- Being tested
- anecortave acetate, 30 mg anecortave acetate
- Keywords
- cornea, transplant, intraocular pressure, steroid response
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anecortave acetateDrug
anterior juxtascleral depot of 15 mg anecortave acetate
30 mg anecortave acetateDrug
anterior juxtascleral depot of 30mg anecortave acetate
| Study group | Role | What they receive |
|---|---|---|
| 30 mg anecortave acetate | Active comparator | Not described Receives: Drug: 30 mg anecortave acetate |
| 15 mg anecortave acetate | Active comparator | Not described Receives: Drug: anecortave acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure Within Normal Limits (<24 mm Hg)
Intraocular pressure was measured by Goldmann applanation tonometry.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionAug 2010
- Study completionSep 2010
Why it stopped: Preliminary data analysis showed insufficient efficacy to justify continuation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TransplantStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornea Research Foundation of America
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francis W. Price, Jr., MD, Principal investigator, Cornea Research Foundation of America
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884039
- Sponsor's protocol ID
- 2007-12
- Status last verified
- Jul 2018
- First submitted
- 17 Apr 2009
- Last updated
- 14 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate Use of Anecortave Acetate: Clinical Protocol for the Treatment of Corticosteroid-induced Intraocular Pressure (IOP) Increases After Corneal Transplantation
- ClinicalTrials.gov ID
- NCT00884039
- Acronym / sponsor ID
- 2007-12
- Conditions
- Transplant, Intraocular Pressure
- Keywords
- cornea, transplant, intraocular pressure, steroid response
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Preliminary data analysis showed insufficient efficacy to justify continuation.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Cornea Research Foundation of AmericaUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 20 Apr 2009 (estimated)
- Results
- Posted 17 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the use of anecortave acetate injection to reduce intraocular pressure (IOP) in corneal transplant recipients who are experiencing steroid-associated pressure control problems. Alternative methods of IOP control have been shown to entail serious risks. For example, reduction of topical steroids increases the risk of graft rejection, and use of glaucoma medications or glaucoma surgery increases the risk of graft failure. This study is designed to have sufficient power to detect whether a single injection can induce a clinically significant IOP reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30 mg anecortave acetate | Active comparator | Drug: 30 mg anecortave acetate |
| 15 mg anecortave acetate | Active comparator | Drug: anecortave acetate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least 18 years of age
- corneal transplant recipient with intraocular pressure (IOP) greater than 24 mmHg and with relative increase in IOP of at least 10 mmHg over the pre-graft baseline
Key exclusion criteria (4 listed)
- not pregnant or lactating
- intraocular surgery in the study eye within 30 days before enrolling in the study
- use of any investigational drug or treatment within 30 days before receipt of study medication
- clinical evidence of scleral thinning
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 |
|---|---|---|
| anecortave acetateanterior juxtascleral depot of 15 mg anecortave acetate | Drug | 15 mg anecortave acetate |
| 30 mg anecortave acetateanterior juxtascleral depot of 30mg anecortave acetate | Drug | 30 mg anecortave acetate |
Primary outcome
Intraocular Pressure Within Normal Limits (<24 mm Hg)
Time frame: 1 month
Intraocular pressure was measured by Goldmann applanation tonometry.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Francis W. Price, Jr., MD principal investigator
Cornea Research Foundation of America
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anecortave acetate and 30 mg anecortave acetate in people with Transplant and Intraocular Pressure, run by Cornea Research Foundation of America 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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 14 Aug 2018. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intraocular Pressure Within Normal Limits (<24 mm Hg) (time frame: 1 month). 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 14 Aug 2018.