Naive Patients With Uncomplicated Proliferative Diabetic RetinopathyPhase 2NCT02151695
Safety and Efficacy of Aflibercept in Proliferative Diabetic Retinopathy.
A Phase 2 study testing panretinal photocoagulation and Aflibercept intravitreal injections in people with Naive Patients With Uncomplicated Proliferative Diabetic Retinopathy, run by Poitiers University Hospital at 1 site in France.
Trial summary
Proliferative diabetic retinopathy is a serious complication of diabetes mellitus, partly consecutive to upregulation of vascular endothelial growth factor (VEGF) as a consequence of retinal ischemia leads. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Naive Patients With Uncomplicated Proliferative Diabetic Retinopathy
- What is being tested?
- panretinal photocoagulation and Aflibercept intravitreal injections
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to 6 Mar 2020
- Phase
- Phase 2
- 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
- Patients with diabetes mellitus type 1 or type 2 complicated by PDR
- Male or female over 18 years
- HbA1c <11.6% at study entry
- Systolic blood pressure <160 mmHg and diastolic blood pressure <105 mmHg at study entry
- Backgrounds clear eye, pupil dilation and patient cooperation sufficient to allow examination or fundus photographs of good quality
Who cannot join
- Hypersensitivity to aflibercept or to any of the excipients
- History of retinal laser (macular or panretinal photocoagulation), of intravitreal injections, of vitrectomy in the eye studied
- PDR associated with tractional retinal detachment in the eye studied
- PDR associated with fibrovascular proliferation in the eye studied
- Florid diabetic retinopathy
- Eye infection or periocular active or suspected
Show all 9Show fewer
- Unbalanced glaucoma in the eye studied
- Other eye disease in the eye studied
- Patients with significant medical problems that may interfere with the evaluation of the safety or efficacy of the treatment studied
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study of Safety and Efficacy of Aflibercept in Proliferative Diabetic Retinopathy.
Proliferative diabetic retinopathy is a serious complication of diabetes mellitus, partly consecutive to upregulation of vascular endothelial growth factor (VEGF) as a consequence of retinal ischemia leads. Aflibercept has been approved by FDA and European medicine agency for treatment of exudative age-related macular degeneration, another retinal disease characterized by choroidal new vessels.
The aim of this pilot study is to evaluate the efficacy and the safety of Aflibercept intravitreal injections compared to panretinal photocoagulation for proliferative diabetic retinopathy.
- Being tested
- panretinal photocoagulation, Aflibercept intravitreal injections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
panretinal photocoagulationProcedure or surgery
Aflibercept intravitreal injectionsDrug
| Study group | Role | What they receive |
|---|---|---|
| Panretinal photocoagulation | Active comparator | Not described Receives: Procedure: panretinal photocoagulation |
| Aflibercept intravitreal injections | Experimental | Not described Receives: Drug: Aflibercept intravitreal injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with regression of retinal neovascularization between baseline and 12th month.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startMay 2015
- Primary completion31 Oct 2018
- Study completion6 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Naive Patients With Uncomplicated Proliferative Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas LEVEZIEL, MD, PhD, Principal investigator, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151695
- Sponsor's protocol ID
- mEdICARE
- Status last verified
- Mar 2019
- First submitted
- 28 May 2014
- Last updated
- 10 Mar 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Safety and Efficacy of Aflibercept in Proliferative Diabetic Retinopathy.
- ClinicalTrials.gov ID
- NCT02151695
- Acronym / sponsor ID
- mEdICARE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 30 May 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.
Proliferative diabetic retinopathy is a serious complication of diabetes mellitus, partly consecutive to upregulation of vascular endothelial growth factor (VEGF) as a consequence of retinal ischemia leads. Aflibercept has been approved by FDA and European medicine agency for treatment of exudative age-related macular degeneration, another retinal disease characterized by choroidal new vessels.
The aim of this pilot study is to evaluate the efficacy and the safety of Aflibercept intravitreal injections compared to panretinal photocoagulation for proliferative diabetic retinopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Panretinal photocoagulation | Active comparator | Procedure: panretinal photocoagulation |
| Aflibercept intravitreal injections | Experimental | Drug: Aflibercept intravitreal injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with diabetes mellitus type 1 or type 2 complicated by PDR
- Male or female over 18 years
- HbA1c <11.6% at study entry
- Systolic blood pressure <160 mmHg and diastolic blood pressure <105 mmHg at study entry
- Backgrounds clear eye, pupil dilation and patient cooperation sufficient to allow examination or fundus photographs of good quality
Key exclusion criteria (9 listed)
- Hypersensitivity to aflibercept or to any of the excipients
- History of retinal laser (macular or panretinal photocoagulation), of intravitreal injections, of vitrectomy in the eye studied
- PDR associated with tractional retinal detachment in the eye studied
- PDR associated with fibrovascular proliferation in the eye studied
- Florid diabetic retinopathy
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 |
|---|---|---|
| panretinal photocoagulation | Procedure or surgery | Panretinal photocoagulation |
| Aflibercept intravitreal injections | Drug | Aflibercept intravitreal injections |
Primary outcome
Percentage of patients with regression of retinal neovascularization between baseline and 12th month.
Time frame: 12 months
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 Mar 2020.
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.
Nicolas LEVEZIEL, MD, PhD principal investigator
Poitiers University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing panretinal photocoagulation and Aflibercept intravitreal injections in people with Naive Patients With Uncomplicated Proliferative Diabetic Retinopathy, run by Poitiers University Hospital at 1 site in France.
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 9 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 Mar 2020. 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 France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percentage of patients with regression of retinal neovascularization between baseline and 12th month. (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 10 Mar 2020.