Diabetic Macular EdemaPhase 1NCT00320814
Phase 1 Study of VEGF Trap in Patients With Diabetic Macular Edema
A Phase 1 study testing VEGF Trap-Eye in people with Diabetic Macular Edema, run by Regeneron Pharmaceuticals at 2 sites in United States.
Trial summary
To assess the ocular and systemic safety and tolerability of a single intravitreal injection of VEGF Trap in patients with diabetic macular edema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- VEGF Trap-Eye
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2006to Aug 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of diabetes mellitus (type 1 or type 2).
- Best corrected E-ETDRS visual acuity score of ≥ 24 letters (i.e., 20/320 or better) and ≤ 73 letters (i.e., 20/40 or worse).
- On clinical exam, definite retinal thickening due to diabetic macular edema involving the center of the macula.
- Retinal Thickness at the center point ≥ 250 microns.
- Media clarity, pupillary dilation, and patient cooperation sufficient for adequate fundus photographs.
Who cannot join
- History of any vitreous hemorrhage within 4 weeks prior to Visit 2 (Day 1).
- Macular edema due to causes other than diabetic macular edema. An eye should be considered ineligible: (1) if the macular edema is considered to be related to cataract extraction or (2) clinical exam and/or OCT suggests that vitreoretinal interface disease (e.g., a taut posterior hyaloid or epiretinal membrane) is the primary cause of the macular edema.
- An ocular condition is present such that, in the opinion of the investigator, visual acuity would not improve from resolution of macular edema (e.g., foveal atrophy, pigmentary changes, dense subfoveal hard exudates, nonretinal condition).
- An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, age-related macular degeneration, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, etc.).
- Presence of any other condition or laboratory abnormality, which, in the opinion of the Investigator, would interfere with the assessment of disease status/progression or jeopardize the patient's appropriate participation in this Phase 1 study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Baltimore, Maryland, 21287
Study site
Charlotte, North Carolina, 28210
About this study
Official title: An Exploratory Study of the Safety, Tolerability and Biological Effect of a Single Intravitreal Administration of VEGF Trap in Patients With Diabetic Macular Edema
To assess the ocular and systemic safety and tolerability of a single intravitreal injection of VEGF Trap in patients with diabetic macular edema.
Read the detailed description
This is an open label study. Initially, 5 patients with DME will receive an ITV injection of VEGF Trap into the study eye. Additional patients may be enrolled at the same or additional dose levels. Patients will be observed for six weeks following the injection for assessments of ocular and systemic safety.
- Conditions
- Diabetic Macular Edema
- Being tested
- VEGF Trap-Eye
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VEGF Trap-EyeDrug
single IVT injection of 4.0 mg of VEGF Trap-Eye into the study eye on Day 1
| Study group | Role | What they receive |
|---|---|---|
| VEGF Trap-Eye | Experimental | single IVT injection of 4.0 mg of VEGF Trap-Eye into the study eye on Day 1 Receives: Drug: VEGF Trap-Eye |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the ocular and systemic safety and tolerability of a single intravitreal (IVT) injection of VEGF Trap-Eye in patients with diabetic macular edema (DME)
Measured: Assessments for safety and tolerablity are performed at each visit (Visit 1 - Visit 10)
Secondary outcomes (2)
To obtain a preliminary assessment of the effect of a single dose of VEGF Trap-Eye on central retinal thickness (CRT) at the center point as determined by optical coherence tomography (OCT)
Measured: Assessments for CRT are performed at each visit (Visit 1 - Visit 10) by means of OCT.
To obtain a preliminary assessment of the effect of a single IVT administration of VEGF Trap-Eye on visual acuity
Measured: Assessments for visual acuity are performed at each visit (Visit 1 - Visit 10).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study startApr 2006
- Primary completionAug 2006
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Avner Ingerman, MD, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00320814
- Sponsor's protocol ID
- VGFT-OD-0512
- Status last verified
- Jun 2011
- First submitted
- 28 Apr 2006
- Last updated
- 10 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of the Safety, Tolerability and Biological Effect of a Single Intravitreal Administration of VEGF Trap in Patients With Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT00320814
- Acronym / sponsor ID
- VGFT-OD-0512
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 3 May 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.
To assess the ocular and systemic safety and tolerability of a single intravitreal injection of VEGF Trap in patients with diabetic macular edema.
Detailed description
This is an open label study. Initially, 5 patients with DME will receive an ITV injection of VEGF Trap into the study eye. Additional patients may be enrolled at the same or additional dose levels. Patients will be observed for six weeks following the injection for assessments of ocular and systemic safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VEGF Trap-Eye | Experimental | Drug: VEGF Trap-Eyesingle IVT injection of 4.0 mg of VEGF Trap-Eye into the study eye on Day 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of diabetes mellitus (type 1 or type 2).
- Best corrected E-ETDRS visual acuity score of ≥ 24 letters (i.e., 20/320 or better) and ≤ 73 letters (i.e., 20/40 or worse).
- On clinical exam, definite retinal thickening due to diabetic macular edema involving the center of the macula.
- Retinal Thickness at the center point ≥ 250 microns.
- Media clarity, pupillary dilation, and patient cooperation sufficient for adequate fundus photographs.
Key exclusion criteria (5 listed)
- History of any vitreous hemorrhage within 4 weeks prior to Visit 2 (Day 1).
- Macular edema due to causes other than diabetic macular edema. An eye should be considered ineligible: (1) if the macular edema is considered to be related to cataract extraction or (2) clinical exam and/or OCT suggests that vitreoretinal interface disease (e.g., a taut posterior hyaloid or epiretinal membrane) is the primary cause of the macular edema.
- An ocular condition is present such that, in the opinion of the investigator, visual acuity would not improve from resolution of macular edema (e.g., foveal atrophy, pigmentary changes, dense subfoveal hard exudates, nonretinal condition).
- An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, age-related macular degeneration, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, etc.).
- Presence of any other condition or laboratory abnormality, which, in the opinion of the Investigator, would interfere with the assessment of disease status/progression or jeopardize the patient's appropriate participation in this Phase 1 study.
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 |
|---|---|---|
| VEGF Trap-Eyesingle IVT injection of 4.0 mg of VEGF Trap-Eye into the study eye on Day 1 | Drug | VEGF Trap-Eye |
Primary outcome
To assess the ocular and systemic safety and tolerability of a single intravitreal (IVT) injection of VEGF Trap-Eye in patients with diabetic macular edema (DME)
Time frame: Assessments for safety and tolerablity are performed at each visit (Visit 1 - Visit 10)
2 secondary outcomes
To obtain a preliminary assessment of the effect of a single dose of VEGF Trap-Eye on central retinal thickness (CRT) at the center point as determined by optical coherence tomography (OCT)
Time frame: Assessments for CRT are performed at each visit (Visit 1 - Visit 10) by means of OCT.
To obtain a preliminary assessment of the effect of a single IVT administration of VEGF Trap-Eye on visual acuity
Time frame: Assessments for visual acuity are performed at each visit (Visit 1 - Visit 10).
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 10 Jun 2011.
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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.
Avner Ingerman, MD study director
Regeneron Pharmaceuticals
2 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 VEGF Trap-Eye in people with Diabetic Macular Edema, run by Regeneron Pharmaceuticals at 2 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 5 inclusion and 5 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 10 Jun 2011. 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 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?
To assess the ocular and systemic safety and tolerability of a single intravitreal (IVT) injection of VEGF Trap-Eye in patients with diabetic macular edema (DME) (time frame: Assessments for safety and tolerablity are performed at each visit (Visit 1 - Visit 10)). 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 10 Jun 2011.