Choroidal NeovascularizationPhase 1NCT01578720
Intravitreal Aflibercept Injection (IAI) for Presumed Ocular Histoplasmosis Syndrome
A Phase 1 study testing EYLEA (Aflibercept) intravitreal injection in people with Choroidal Neovascularization and Presumed Ocular Histoplasmosis, run by Retina Research Institute, LLC at 3 sites in United States.
Trial summary
The purpose of this study is to assess the efficacy and safety of intravitreal injection of aflibercept for the treatment of Choroidal Neovascularization (CNV) secondary to presumed ocular histoplasmosis syndrome (POHS). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Choroidal Neovascularization, Presumed Ocular Histoplasmosis
- What is being tested?
- EYLEA (Aflibercept) intravitreal injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2012to Mar 2015
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CNV of less than 1 year duration due to presumed ocular histoplasmosis
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age 21 years and older
- Subfoveal or juxtafoveal CNV lesion of less than 5400um in diameter
- Best corrected visual acuity of 20/25 to 20/400
- Birth control therapy for females of child-bearing age
Who cannot join
- CNV due to presumed ocular histoplasmosis for greater than 1 year
- Pregnancy (positive pregnancy test) or lactation
- Premenopausal women not using adequate contraception. The following are considered effective means of contraception : surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch
- A recent history of smoking (within 1 year of study enrollment)
- Prior treatment with intravitreal aflibercept injection
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
Show all 23Show fewer
- Uncontrolled glaucoma in the study eye (defined as IOP greater or equal to 30 mmHg despite treatment with anti-glaucoma medication)
- History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- Presence of significant subfoveal fibrosis or atrophy
- Intraocular surgery (including cataract surgery) in the study eye within 2 months of enrollment
- Active intraocular inflammation (grade trace or above) in the study eye
- History of allergy to fluorescein, ICG or iodine, not amendable to treatment
- Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either
- Require medical or surgical intervention during the 12 month study period to prevent or treat visual loss that might result from that condition, or
- If allowed to progress untreated, could likely contribute to loss of at least 2 snellen equivalent lines of BCVA over the 12 month study period
- Prior/Concomitant Treatment:
- Panretinal photocoagulation treatment
- Previous intraocular steroids or PDT within 3 months
- Previous participation in any studies of investigational drugs within 30 days preceding Day 0 (excluding vitamins and minerals)
- Previous treatment with intravitreally (in either eye) or intravenously administered Avastin (bevacizumab) within 60 days
- Previous use of Macugen or Lucentis in study eye within 60 days
- Prior submacular or vitreous surgery
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Retina Institute
St Louis, Missouri, 63017
The Retina Institute
St Louis, Missouri, 63128
The Retina Institute
St Louis, Missouri, 63144
About this study
Official title: Treatment of CNV Secondary to Presumed Ocular Histoplasmosis With EYLEA 2.0mg (Intravitreal Aflibercept Injection)
The purpose of this study is to assess the efficacy and safety of intravitreal injection of aflibercept for the treatment of Choroidal Neovascularization (CNV) secondary to presumed ocular histoplasmosis syndrome (POHS).
- Being tested
- EYLEA (Aflibercept) intravitreal injection
- Medical subject headings
- Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EYLEA (Aflibercept) intravitreal injectionDrug
Intravitreal Injection once every 8 weeks with 3 initial monthly doses
| Study group | Role | What they receive |
|---|---|---|
| IVT injection once every 8 weeks after 3 initial monthly doses | Other | Intravitreal aflibercept injection 2.0mg dosed every 4 weeks (monthly)for the first 3 months followed by 2.0 mg (0.05mL) via intravitreal injection every eight weeks (2 months).
Dosing at monthly intervals is allowed if needed in the opinion of the investigator based on presence of fluid on OCT and/or a decrease in visual acuity of greater than or equal to 5 letters from the previous visit. Receives: Drug: EYLEA (Aflibercept) intravitreal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
The Incidence \& Severity will be assessed during study participation. Baseline medical conditions \& abnormal findings present prior to the patient signing the Informed Consent Form (ICF)will be recorded as pre-existing illnesses in the medical history. Clinical study staff will start assessing subjects for adverse events once the ICF has been signed starting at month 1 and at each monthly visit,and will be instructed to request the adverse event information in a nonspecific, non-suggestive type of questioning. The Investigators will record all adverse events regardless of causality.
Measured: 12 months
Secondary outcomes (6)
Mean visual acuity (BCVA) at Months 6 and 12
Measured: Month 6 and Month 12
Mean change in OCT central foveal thickness from baseline at Months 6 and 12
Measured: Months 6 and 12
Mean change in Macular Volume from baseline at Months 6 and 12
Measured: Months 6 and 12
Mean change in visual acuity (BCVA) from baseline at Months 6 and 12
Measured: Months 6 and 12
Mean change in CNV lesion characteristics (size, leakage, etc.) from baseline at Months 6 and 12
Measured: Months 6 and 12
Proportion of patients with no fluid on OCT (absence of cystic edema and subretinal fluid) at Months 6 and 12
Measured: Months 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startJun 2012
- Primary completionApr 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choroidal NeovascularizationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Retina Research Institute, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rhonda Weeks, Retina Research Institute, LLC
- Investigators
- Kevin J Blinder, MD, Principal investigator, The Retina Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578720
- Sponsor's protocol ID
- KB-001
- Status last verified
- Aug 2018
- First submitted
- 2 Apr 2012
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of CNV Secondary to Presumed Ocular Histoplasmosis With EYLEA 2.0mg (Intravitreal Aflibercept Injection)
- ClinicalTrials.gov ID
- NCT01578720
- Acronym / sponsor ID
- KB-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Retina Research Institute, LLCUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 17 Apr 2012 (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 assess the efficacy and safety of intravitreal injection of aflibercept for the treatment of Choroidal Neovascularization (CNV) secondary to presumed ocular histoplasmosis syndrome (POHS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IVT injection once every 8 weeks after 3 initial monthly doses | Other | Drug: EYLEA (Aflibercept) intravitreal injectionIntravitreal aflibercept injection 2.0mg dosed every 4 weeks (monthly)for the first 3 months followed by 2.0 mg (0.05mL) via intravitreal injection every eight weeks (2 months). Dosing at monthly intervals is allowed if needed in the opinion of the investigator based on presence of fluid on OCT and/or a decrease in visual acuity of greater than or equal to 5 letters from the previous visit. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- CNV of less than 1 year duration due to presumed ocular histoplasmosis
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age 21 years and older
- Subfoveal or juxtafoveal CNV lesion of less than 5400um in diameter
- Best corrected visual acuity of 20/25 to 20/400
Key exclusion criteria (23 listed)
- CNV due to presumed ocular histoplasmosis for greater than 1 year
- Pregnancy (positive pregnancy test) or lactation
- Premenopausal women not using adequate contraception. The following are considered effective means of contraception : surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch
- A recent history of smoking (within 1 year of study enrollment)
- Prior treatment with intravitreal aflibercept injection
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 |
|---|---|---|
| EYLEA (Aflibercept) intravitreal injectionIntravitreal Injection once every 8 weeks with 3 initial monthly doses | Drug | IVT injection once every 8 weeks after 3 initial monthly doses |
Primary outcome
Safety
Time frame: 12 months
The Incidence \& Severity will be assessed during study participation. Baseline medical conditions \& abnormal findings present prior to the patient signing the Informed Consent Form (ICF)will be recorded as pre-existing illnesses in the medical history. Clinical study staff will start assessing subjects for adverse events once the ICF has been signed starting at month 1 and at each monthly visit,and will be instructed to request the adverse event information in a nonspecific, non-suggestive type of questioning. The Investigators will record all adverse events regardless of causality.
6 secondary outcomes
Mean visual acuity (BCVA) at Months 6 and 12
Time frame: Month 6 and Month 12
Mean change in OCT central foveal thickness from baseline at Months 6 and 12
Time frame: Months 6 and 12
Mean change in Macular Volume from baseline at Months 6 and 12
Time frame: Months 6 and 12
Mean change in visual acuity (BCVA) from baseline at Months 6 and 12
Time frame: Months 6 and 12
Mean change in CNV lesion characteristics (size, leakage, etc.) from baseline at Months 6 and 12
Time frame: Months 6 and 12
Proportion of patients with no fluid on OCT (absence of cystic edema and subretinal fluid) at Months 6 and 12
Time frame: Months 6 and 12
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 29 Aug 2018.
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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.
Kevin J Blinder, MD principal investigator
The Retina Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EYLEA (Aflibercept) intravitreal injection in people with Choroidal Neovascularization and Presumed Ocular Histoplasmosis, run by Retina Research Institute, LLC at 3 sites 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 6 inclusion and 23 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 29 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 3 sites 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?
Safety (time frame: 12 months). 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 29 Aug 2018.