Diabetic Macular EdemaPhase 1NCT02103283
A Phase 1, Open-Label Study of Teprotumumab in Patients With Diabetic Macular Edema (DME)
A Phase 1 study testing Teprotumumab in people with Diabetic Macular Edema, run by Amgen at 3 sites in United States.
Trial summary
A Phase 1 Study to evaluate the Safety of teprotumumab 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?
- Teprotumumab
- 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
- Oct 2014to Aug 2016
- 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 with Hemoglobin A1c <8.5%
- IGF 1 in serum > 106 ng/mL
- Women of child-bearing potential must have negative pregnancy test and be willing and able to use two different methods of contraception, one of which must be oral contraceptive or depot formulation. Males must be surgically sterile or agree to use barrier contraception
- Clinically significant DME of less than 12 months duration
- Non-proliferative diabetic retinopathy of moderate severity
- Best corrected electronic ETDRS letter score < 78 and > 24
Who cannot join
- Unstable-uncontrolled diabetes as demonstrated by a change in diabetes medication greater than 15% in the previous 60 days.
- Significant renal disease, myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure
- Blood pressure > 180/110
- Anti-vascular endothelial growth factor (VEGF) treatment within two months prior to enrollment
- History of pan retinal photocoagulation within four months prior to enrollment
- History of ocular surgery within four months prior to enrollment
- History of systemic treatment with corticosteroids within 3 months prior to enrollment
Trial locations and contacts
3 sites in 1 country.
United States3 sites
David S Boyer
Beverly Hills, California, 90211
Diana Do, MD
Omaha, Nebraska, 68106
David A Eichenbaum, MD
St. Petersburg, Florida, 33711
About this study
Official title: Phase 1, Open-Label Safety and Pharmacodynamic Study of RV001, an Insulin-Like Growth Factor-1 Receptor (IGF-1R) Antagonist, Administered by Intravenous (IV) Infusion in Patients With Diabetic Macular Edema (DME)
A Phase 1 Study to evaluate the Safety of teprotumumab in Patients with Diabetic Macular Edema.
Read the detailed description
A Phase 1, Open-Label Safety and Pharmacodynamic Study of RV 001, an Insulin-Like Growth Factor-1 Receptor (IGF-1) Antagonist, Given By IV Infusion in Patients with Diabetic Macular Edema (DME).
- Conditions
- Diabetic Macular Edema
- Being tested
- Teprotumumab
- Keywords
- Diabetic Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeprotumumabDrug
Also called RV 001
Teprotumumab 20mg/kg administered by intravenous infusion every 3 weeks for 3 infusions
| Study group | Role | What they receive |
|---|---|---|
| Teprotumumab | Experimental | Teprotumumab 20mg/kg administered by intravenous infusion every 3 weeks for 3 infusions Receives: Drug: Teprotumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of RV001in subjects with Diabetic Macular Edema
Number of subjects with adverse events, serious adverse events and early discontinuations due to adverse events. Number of subjects with clinical significant abnormal laboratory values, electrocardiograms (pre and post infusions), abnormal vital signs, ophthalmic and physical examinations.
Measured: Change from Baseline to Week 9
Secondary outcomes (1)
Safety of RV001in subjects with Diabetic Macular Edema
Pharmacodynamic measure includes change in Optical Coherence Tomography, Fluorescein Angiography and Stereoscopic color funds photos findings.
Measured: Change from Baseline to Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2016
- Study completionAug 2016
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 AmgenThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103283
- Sponsor's protocol ID
- DME01RV
- Status last verified
- Jun 2025
- First submitted
- 27 Mar 2014
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-Label Safety and Pharmacodynamic Study of RV001, an Insulin-Like Growth Factor-1 Receptor (IGF-1R) Antagonist, Administered by Intravenous (IV) Infusion in Patients With Diabetic Macular Edema (DME)
- ClinicalTrials.gov ID
- NCT02103283
- Acronym / sponsor ID
- DME01RV
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic Macular Edema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 3 Apr 2014 (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.
A Phase 1 Study to evaluate the Safety of teprotumumab in Patients with Diabetic Macular Edema.
Detailed description
A Phase 1, Open-Label Safety and Pharmacodynamic Study of RV 001, an Insulin-Like Growth Factor-1 Receptor (IGF-1) Antagonist, Given By IV Infusion in Patients with Diabetic Macular Edema (DME).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Teprotumumab | Experimental | Drug: TeprotumumabTeprotumumab 20mg/kg administered by intravenous infusion every 3 weeks for 3 infusions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of diabetes mellitus with Hemoglobin A1c <8.5%
- IGF 1 in serum > 106 ng/mL
- Women of child-bearing potential must have negative pregnancy test and be willing and able to use two different methods of contraception, one of which must be oral contraceptive or depot formulation. Males must be surgically sterile or agree to use barrier contraception
- Clinically significant DME of less than 12 months duration
- Non-proliferative diabetic retinopathy of moderate severity
Key exclusion criteria (7 listed)
- Unstable-uncontrolled diabetes as demonstrated by a change in diabetes medication greater than 15% in the previous 60 days.
- Significant renal disease, myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure
- Blood pressure > 180/110
- Anti-vascular endothelial growth factor (VEGF) treatment within two months prior to enrollment
- History of pan retinal photocoagulation within four months prior to enrollment
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 |
|---|---|---|
| TeprotumumabAlso: RV 001Teprotumumab 20mg/kg administered by intravenous infusion every 3 weeks for 3 infusions | Drug | Teprotumumab |
Primary outcome
Safety of RV001in subjects with Diabetic Macular Edema
Time frame: Change from Baseline to Week 9
Number of subjects with adverse events, serious adverse events and early discontinuations due to adverse events. Number of subjects with clinical significant abnormal laboratory values, electrocardiograms (pre and post infusions), abnormal vital signs, ophthalmic and physical examinations.
1 secondary outcome
Safety of RV001in subjects with Diabetic Macular Edema
Time frame: Change from Baseline to Week 9
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 25 Jun 2025.
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Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
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COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
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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.
MD study director
Amgen
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 Teprotumumab in people with Diabetic Macular Edema, run by Amgen 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 7 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 25 Jun 2025. 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 of RV001in subjects with Diabetic Macular Edema (time frame: Change from Baseline to Week 9). 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 25 Jun 2025.