Dexamethasone Intravitreal Implant in Retinal Vein Occlusion

NCT03559491 | Completed

• 1 other identifier: 2018oculistica
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Purpose: To evaluate retinal functional improvement by means of visual acuity and retinal sensibility examination after intravitreal dexamethasone implant in patients affected by cystoid macular edema secondary to retinal vein occlusion.

Conditions

Macular Edema, Cystoid

Keywords

steroid; retinal vein occlusion; macular edema

Outcome Measures

Primary Outcomes (2)

• Visual acuity

  evaluation of visual acuity

  6 months

• retinal sensibility

  microperimetry evaluation

  6 months

Study Arms (1)

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.

Drug: Intravitreal injection

Interventions

Intravitreal injection DRUG

Long term release steroid injection

Macular Edema Patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by cystoid macular edema (CME) due to retinal vein occlusion of recent onset (less than three months) were enrolled

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead

Related Publications (3)

• Querques G, Lattanzio R, Querques L, Triolo G, Cascavilla ML, Cavallero E, Del Turco C, Casalino G, Bandello F. Impact of intravitreal dexamethasone implant (Ozurdex) on macular morphology and function. Retina. 2014 Feb;34(2):330-41. doi: 10.1097/IAE.0b013e31829f7495.

  PMID: 23945638 BACKGROUND

• Garweg JG, Zandi S. Impact of treatment on long-term visual function in retinal vein occlusion-response to the comment on: retinal vein occlusion and the use of a dexamethasone intravitreal implant (Ozurdex(R)) in its treatment. Graefes Arch Clin Exp Ophthalmol. 2016 Dec;254(12):2479-2480. doi: 10.1007/s00417-016-3459-y. Epub 2016 Sep 7. No abstract available.

  PMID: 27604764 RESULT

• Donati S, Gandolfi C, Caprani SM, Cattaneo J, Premoli L, Azzolini C. Evaluation of the Effectiveness of Treatment with Dexamethasone Intravitreal Implant in Cystoid Macular Edema Secondary to Retinal Vein Occlusion. Biomed Res Int. 2018 Aug 2;2018:3095961. doi: 10.1155/2018/3095961. eCollection 2018.

  PMID: 30175123 DERIVED

MeSH Terms

Conditions

Macular Edema; Retinal Vein Occlusion

Interventions

Intravitreal Injections

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Injections, Intraocular; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Simone Donati, MD

  Università dell'Insubria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Investigator

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: June 18, 2018
• Study Start: October 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: December 31, 2017
• Last Updated: June 18, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share