Diabetic Macular EdemaREGARD1NCT03157206
Diabetic Retinopathy Assessed by Ultra-wide
An observational study of Diabetic Macular Edema, run by Association Pour La Recherche En Vision Du Service D'Ophtalmologie De L'Hôpital at 1 site in France.
Trial summary
Patients with diabetic macular edema treated with aflibercept injections for visual impairment will be observed in standard care during 12 months. They will undergo visual assessments by Ultrawide Field angiography at baseline and at 12 months Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- How many people
- 49 participants
- Where
- 1 siteFrance
- Study dates
- 19 Apr 2017to 18 Sep 2020
- Phase
- Observational
- 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
Study population: Diabetic patients (type 1 or 2) over 18 years of age with mild to severe non proliferative diabetic retinopathy and diabetic macular edema
Who may be able to join
- Male or female patients, ≥ 18 years
- type 1 or type2 diabetes mellitus
- patients with at least 1 eye with best corrected visual acuity (BCVA) between 24 and 78 ETDRS letters due to center-involved diabetic macular edema (DME). DME was defined by a central retinal thickness (CRT) >300µm and the loss of foveal pit on SD-OCT
- Aflibercept treatment administred
- Afilliated to social security scheme
- agree to participate
Who cannot join
- History of treatment with any anti-VEGF agents within 12 months prior to inclusion
- Application of any intra-vitreal treatment within 12 months prior to inclusion
- Any aflibercept contraindication
- History of panretinal photocoagulation laser (PRP)
- Proliferative diabetic retinopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peripheral Ischemia Evolution Assessed by Ultra-wide Field Angiography in Patients With Diabetic Macular Edema
Patients with diabetic macular edema treated with aflibercept injections for visual impairment will be observed in standard care during 12 months. They will undergo visual assessments by Ultrawide Field angiography at baseline and at 12 months
Read the detailed description
Diabetic retinopathy imaged by ultra wide field angiography (200°): the California (Optos, Scotland) allows ultrawide field pictures of 200° of the retina. This new imaging allows seeing beyond what was seen by the classic 7 ETDRS fields angiography:
- In pivotal studies assessing the effect of antiVEGFs on diabetic retinopathy (DR) in patients treated for diabetic macular edema (DME), ETDRS DR classification was used based on the 7 classical ETDRS field fundus photographs. However, it has been identify that antiVEGF may modified the semiology (hemorrhages, micro-aneurisms) and consecutively modify the stage of DR. There is no assessment of the regression of peripheral ischemia of the retina (non perfused retina) by angiography during an antiVEGF treatment.
- DR severity score (1) based on ETDRS classification assess the number of retinal lesions within the 7 classic retinal fields corresponding to around 30% of the total retina. It has been recently shown that peripheral lesions non visible on the classic 7 fields angiography could be predictive of progression of DR (2,3) at 4 years of follow-up independently of the initial stage of DR, HbA1C level, and could be new arguments for Laser treatment. This UWF imaging could help to understand some cases of patients with worst progression than expected, and to identify new therapeutic indications (4). These UWF pictures need to be explored in order to better characterize the severity of DR forms and probably find new therapeutics.
Impact of anti VEGF treatments on DR: pivotal studies assessing the efficacy of ranibizumab on DME explored also the effect of antiVEGFs on DR. One of the secondary endpoints of RISE and RIDE (5) studies, comparing the effect of ranibizumab 0.3mg versus 0.5mg versus sham injections, was the rate of new proliferative DR (PDR). This rate was of 33.8% in the sham group versus 11% in the treated group at 2 years of follow-up.
In Protocole I (6), the DRCRnet, found a 2 times lower risk to evolve toward PDR in case of ranibizumab treatment versus sham (7).
VIVID and VISTA showed at least 2 ETDRS steps improvement of DR for 30% of patients treated by aflibercept versus 8.2% to 15.6% at 2 years in the sham group.
It would be very interesting to have complementary data on improvement and worsening of DR under antiVEGF treatment with an angiographic analysis of the retinal periphery perfusion on larger field of the fundus than we usually have, and instead of color fundus photographs usually available in pivotal study to assess DR severity.
The purpose of this study is to characterize at one year the effect of aflibercept used for DME treatment on retinal periphery assessed by UWF angiography instead of the classic 7 ETDRS fields in order to quantify ischemia.
- Conditions
- Diabetic Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DME patients treated with aflibercept | angiography by ultrawide field |
What is being measured
The primary outcome is the main question the study is designed to answer.
AntiVEGF effects on best visual acuity
Retinian peripheral ischemia decrease
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 posted17 May 2017
- Study start19 Apr 2017
- Primary completion18 Jul 2019 (estimated)
- Study completion18 Sep 2020 (estimated)
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association Pour La Recherche En Vision Du Service D'Ophtalmologie De L'Hôpital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157206
- Sponsor's protocol ID
- avoph_RNI_2016-001
- Acronym
- REGARD1
- Status last verified
- May 2017
- First submitted
- 12 May 2017
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Ischemia Evolution Assessed by Ultra-wide Field Angiography in Patients With Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT03157206
- Acronym / sponsor ID
- REGARD1 / avoph_RNI_2016-001
- Conditions
- Diabetic Macular Edema
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Association Pour La Recherche En Vision Du Service D'Ophtalmologie De L'HôpitalUniversity, hospital or other
- Study start
- 19 Apr 2017 (actual)
- Primary completion
- 18 Jul 2019 (estimated)
- Study completion
- 18 Sep 2020 (estimated)
- First posted
- 17 May 2017 (actual)
- 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.
Patients with diabetic macular edema treated with aflibercept injections for visual impairment will be observed in standard care during 12 months. They will undergo visual assessments by Ultrawide Field angiography at baseline and at 12 months
Detailed description
Diabetic retinopathy imaged by ultra wide field angiography (200°): the California (Optos, Scotland) allows ultrawide field pictures of 200° of the retina. This new imaging allows seeing beyond what was seen by the classic 7 ETDRS fields angiography:
- In pivotal studies assessing the effect of antiVEGFs on diabetic retinopathy (DR) in patients treated for diabetic macular edema (DME), ETDRS DR classification was used based on the 7 classical ETDRS field fundus photographs. However, it has been identify that antiVEGF may modified the semiology (hemorrhages, micro-aneurisms) and consecutively modify the stage of DR. There is no assessment of the regression of peripheral ischemia of the retina (non perfused retina) by angiography during an antiVEGF treatment.
- DR severity score (1) based on ETDRS classification assess the number of retinal lesions within the 7 classic retinal fields corresponding to around 30% of the total retina. It has been recently shown that peripheral lesions non visible on the classic 7 fields angiography could be predictive of progression of DR (2,3) at 4 years of follow-up independently of the initial stage of DR, HbA1C level, and could be new arguments for Laser treatment. This UWF imaging could help to understand some cases of patients with worst progression than expected, and to identify new therapeutic indications (4). These UWF pictures need to be explored in order to better characterize the severity of DR forms and probably find new therapeutics.
Impact of anti VEGF treatments on DR: pivotal studies assessing the efficacy of ranibizumab on DME explored also the effect of antiVEGFs on DR. One of the secondary endpoints of RISE and RIDE (5) studies, comparing the effect of ranibizumab 0.3mg versus 0.5mg versus sham injections, was the rate of new proliferative DR (PDR). This rate was of 33.8% in the sham group versus 11% in the treated group at 2 years of follow-up.
In Protocole I (6), the DRCRnet, found a 2 times lower risk to evolve toward PDR in case of ranibizumab treatment versus sham (7).
VIVID and VISTA showed at least 2 ETDRS steps improvement of DR for 30% of patients treated by aflibercept versus 8.2% to 15.6% at 2 years in the sham group.
It would be very interesting to have complementary data on improvement and worsening of DR under antiVEGF treatment with an angiographic analysis of the retinal periphery perfusion on larger field of the fundus than we usually have, and instead of color fundus photographs usually available in pivotal study to assess DR severity.
The purpose of this study is to characterize at one year the effect of aflibercept used for DME treatment on retinal periphery assessed by UWF angiography instead of the classic 7 ETDRS fields in order to quantify ischemia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DME patients treated with aflibercept | – | –angiography by ultrawide field |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic patients (type 1 or 2) over 18 years of age with mild to severe non proliferative diabetic retinopathy and diabetic macular edema
Key inclusion criteria (6 listed)
- Male or female patients, ≥ 18 years
- type 1 or type2 diabetes mellitus
- patients with at least 1 eye with best corrected visual acuity (BCVA) between 24 and 78 ETDRS letters due to center-involved diabetic macular edema (DME). DME was defined by a central retinal thickness (CRT) >300µm and the loss of foveal pit on SD-OCT
- Aflibercept treatment administred
- Afilliated to social security scheme
Key exclusion criteria (5 listed)
- History of treatment with any anti-VEGF agents within 12 months prior to inclusion
- Application of any intra-vitreal treatment within 12 months prior to inclusion
- Any aflibercept contraindication
- History of panretinal photocoagulation laser (PRP)
- Proliferative 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.
Primary outcome
AntiVEGF effects on best visual acuity
Time frame: 12 months
Retinian peripheral ischemia decrease
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Macular Edema, run by Association Pour La Recherche En Vision Du Service D'Ophtalmologie De L'Hôpital 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 6 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: status not confirmed, as of the sponsor's last update on 8 Jun 2017. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Audrey GIOCANTI - AUREGAN, MD-PhD (33148955218, audrey.giocanti@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AntiVEGF effects on best visual acuity (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 8 Jun 2017.