Dexamethasone Intravitreal Implant in Retinal Vein Occlusion
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| ClinicalTrials.gov Identifier: NCT03559491 |
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Recruitment Status :
Completed
First Posted : June 18, 2018
Last Update Posted : June 18, 2018
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| Condition or disease | Intervention/treatment |
|---|---|
| Macular Edema, Cystoid | Drug: Intravitreal injection |
Cystoid macular edema represents the most important cause of visual impairment after retinal vein occlusion. The etiological factors of this complication are under investigation, from inflammatory cytokines to the breakdown of vascular barrier with increased permeability and diffusion of angiogenic factors. Clinical research developed different drugs and therapeutic strategies to treat and control macular edema, to evaluate the correct timetable and to reach long-term clinical significative results. At now, different experiences have been published with available drugs, from steroids to anti Vascular Endothelial Growth Factor. A debate still remains about the correct approach, the correct combination of drugs (if necessary) and the correct evaluation of drug effectiveness.
In our study, we will evaluate extensive functional recovery and its relation to macular thickness after steroid injection. Considering that visual acuity reflects only foveal function, it may not be sufficient to evaluate the overall function on the macular area. We introduce microperimetry study as a valuable and reproducible tool to create a functional mapping of the entire macula.
| Study Type : | Observational |
| Actual Enrollment : | 30 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Evaluation of the Effectiveness of Treatment With Dexamethasone Intravitreal Implant in Cystoid Macular Edema Secondary to Retinal Vein Occlusion |
| Study Start Date : | October 2015 |
| Actual Primary Completion Date : | October 1, 2017 |
| Actual Study Completion Date : | December 31, 2017 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Macular Edema Patients
Patients affected by cystoid macular edema (CME) due to retinal vein occlusion of recent onset (less than three months) will be enrolled.
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Drug: Intravitreal injection
Long term release steroid injection |
- Visual acuity [ Time Frame: 6 months ]evaluation of visual acuity
- retinal sensibility [ Time Frame: 6 months ]microperimetry evaluation
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| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion criteria were: age older than 18 years; CME secondary to retinal vein occlusion, disease duration inferior to 12 weeks; best-corrected visual acuity (BCVA) between 20/200 and 20/25 (Snellen equivalent) in the study eye at baseline examination, central retinal thickness (CRT) superior to 300 mm, as measured by optical coherence tomography at baseline examination.
The exclusion criteria were any ocular surgery in the study eye in the past 6 months; diabetes mellitus with signs of diabetic retinopathy; previous laser photocoagulation; previous intravitreal injection of corticosteroids or anti-vascular endothelial growth factor; a history of ocular inflammation; marked retinal ischemia or retinal hemorrhages (in particular in macular region involving the fovea); any other ocular condition such as anterior ischemic neuropathy, amblyopia or significant media opacities; significant alteration on epiretinal surface such as epiretinal membrane or vitreomacular traction; uncontrolled or advanced glaucoma; any uncontrolled systemic disease.
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): NCT03559491
| Principal Investigator: | Simone Donati, MD | Università dell'Insubria |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Simone Donati, Study Investigator, Università degli Studi dell'Insubria |
| ClinicalTrials.gov Identifier: | NCT03559491 |
| Other Study ID Numbers: |
2018oculistica |
| First Posted: | June 18, 2018 Key Record Dates |
| Last Update Posted: | June 18, 2018 |
| Last Verified: | June 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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steroid retinal vein occlusion macular edema |
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Macular Edema Retinal Vein Occlusion Edema Macular Degeneration Retinal Degeneration Retinal Diseases |
Eye Diseases Venous Thrombosis Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |