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Multimodal Image Study of Retinal Inflammation Markers After Corticoid and Antiangiogenic Treatment in Pacients With Diabetic Macular Edema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03583242
Recruitment Status : Unknown
Verified June 2018 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Recruitment status was:  Recruiting
First Posted : July 11, 2018
Last Update Posted : July 11, 2018
Sponsor:
Collaborator:
Spanish Clinical Research Network ISCIII
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary:
  • Main objective: Inflammation factors in imaging techniques of diabetic macular edema
  • Prospective observational design
  • Disease under study: Diabetic macular edema
  • Methodology: Collection of the image data in the usual control (baseline visit, 4th month)
  • Population under study and total number of subjects Diabetics with macular edema.
  • Approximate N: 80 pacients.
  • Expected duration of the study: 12 months.

Condition or disease Intervention/treatment
Diabetic Macular Edema Drug: Antiangiogenic Agents Drug: Corticosteroid

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Multimodal Image Study of Retinal Inflammation Markers After Corticoid and Antiangiogenic Treatment in Pacients With Diabetic Macular Edema
Actual Study Start Date : May 23, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema Steroids

Group/Cohort Intervention/treatment
DME treat with antiangiogenic
  • 3 Intravitreal injections of 0.05 ml of Aflibercept (40 mg/ml) during 3 months (one per month) The clinical management of the patients will be adapted to the treatment standards of the Ophthalmology Service of the Hospital de la Santa Creu and Sant Pau, without the realization of this study influencing such process.
  • 1 Injection of dexamethasone intravitreal implant 0.7mg. The clinical management of the patients will be adapted to the treatment standards of the Ophthalmology Service of the Hospital de la Santa Creu and Sant Pau, without the realization of this study influencing such process.
Drug: Antiangiogenic Agents
3 Intravitreal injections of 0.05 ml of Aflibercept (40 mg/ml) during 3 months (one per month) The clinical management of the patients will be adapted to the treatment standards of the Ophthalmology Service of the Hospital de la Santa Creu and Sant Pau, without the realization of this study influencing such process.

Drug: Corticosteroid
1 Injection of dexamethasone intravitreal implant 0.7mg. The clinical management of the patients will be adapted to the treatment standards of the Ophthalmology Service of the Hospital de la Santa Creu and Sant Pau, without the realization of this study influencing such process.




Primary Outcome Measures :
  1. Macular thickness [ Time Frame: At first visit and 4 months after the first intravitreal injection ]
    Measured by OCT in micrometer

  2. Coroidal thickness [ Time Frame: At first visit and 4 months after the first intravitreal injection ]
    Measured by OCT (EDI mode) in micrometer

  3. Numbers of hyperreflective intraretinal spots [ Time Frame: At first visit and 4 months after the first intravitreal injection ]
    Measured by OCT scans

  4. Increased macular autofluorescence [ Time Frame: At first visit and 4 months after the first intravitreal injection ]
    Autofluorescence of the fundus


Secondary Outcome Measures :
  1. Best corrected visual acuity [ Time Frame: At first visit and 4 months after the first intravitreal injection ]
    Visual acuity test: ETDRS at 4 meters

  2. Type of diabetic macular edema [ Time Frame: At first visit and 4 months after the first intravitreal injection ]
    Direct visualization with OCT images: cystic, subretinal fluid, spongiform

  3. Presence of epiretinal membrane [ Time Frame: At first visit and 4 months after the first intravitreal injection ]
    Direct visualization with OCT images

  4. Disruption of ellipsoid line and external limiting membrane [ Time Frame: At first visit and 4 months after the first intravitreal injection ]
    Direct visualization with OCT images

  5. Disorganization of the retinal inner layers [ Time Frame: At first visit and 4 months after the first intravitreal injection ]
    Direct visualization with OCT images

  6. Subfoveal neuroretinal detachment [ Time Frame: At first visit and 4 months after the first intravitreal injection ]
    Direct visualization with OCT images



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any adult patient adult with diabetic macular edema in external consultations of our department that require intravitravitreal treatment according to daily clinical practice and that satisfy inclusion an exclusion criteria.
Criteria

Inclusion Criteria:

  • Diagnostic of diabetic macular edema
  • Without any intravitreal treatment during the last three months
  • Patients who require intravitreal corticoid or antiangiogenic treatment following the usual clinical practice

Exclusion Criteria:

  • Any other macular pathology ( for exemple age-related macular degeneration)
  • Proliferative diabetic retinopathy
  • Any other eye involvement that may influence visual acuity (eg, uncontrolled glaucoma)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03583242


Contacts
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Contact: Clément Passabosc, MD +34608251347 cpassabosc@alumni.unav.es

Locations
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Spain
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Clément Passabosc, MD         
Principal Investigator: Jose I Vela, MD PhD         
Sub-Investigator: Clément Passabosc, MD         
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Spanish Clinical Research Network ISCIII
Publications:

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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT03583242    
Other Study ID Numbers: IIBSP-RET-2018-13
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Edema
Inflammation
Edema
Pathologic Processes
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents