Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)

NCT01660802 | Completed Phase 3 Results

• 1 other identifier: 206207-020
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the safety and efficacy of 700 μg dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System in patients with macular edema in a 6 month double-blind period versus sham followed by a 2 month open label period.

Conditions

Macular Edema

Outcome Measures

Primary Outcomes (1)

• Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye

  BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.

  Baseline, 6 Months

Secondary Outcomes (3)

• Average Change From Baseline in BCVA in the Study Eye

  Baseline, 6 Months

• Change From Baseline in BCVA in the Study Eye

  Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6

• Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye

  Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6

Study Arms (2)

700 μg Dexamethasone

EXPERIMENTAL

700 μg Dexamethasone intravitreal injection in the study eye on Day 1.

Drug: 700 μg Dexamethasone

Sham

SHAM COMPARATOR

Sham administered in the study eye on Day 1.

Drug: 700 μg Dexamethasone; Other: Sham

Interventions

700 μg Dexamethasone DRUG

700 μg Dexamethasone intravitreal injection in the study eye on Day 1.

Also known as: Ozurdex®

700 μg Dexamethasone; Sham

Sham OTHER

Sham administered in the study eye on Day 1.

Sham

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of macular edema defined as macular thickening involving the center of the macula due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)

You may not qualify if:

• History of glaucoma, ocular hypertension or optic nerve head change
• Any active bacterial, viral, parasitic, or fungal infections in either eye
• Eye surgery, including cataract surgery, and/or laser of any type in the study eye within 3 months prior to study start
• History of use of intravitreal steroids or any intravitreal injectable drug in the study eye within 3 months prior to study start
• Use of oral, intravenous, intramuscular, epidural, rectal, or extensive dermal steroids within 1 month prior to study start
• Use of immunosuppressants, immunomodulators, antimetabolites, and/or alkylating agents within 3 months prior to study start
• Use of topical ophthalmic corticosticosteroids within 2 weeks of study start

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Beijing, China

Location

Related Publications (1)

• Li X, Wang N, Liang X, Xu G, Li XY, Jiao J, Lou J, Hashad Y; China Ozurdex in RVO Study Group. Safety and efficacy of dexamethasone intravitreal implant for treatment of macular edema secondary to retinal vein occlusion in Chinese patients: randomized, sham-controlled, multicenter study. Graefes Arch Clin Exp Ophthalmol. 2018 Jan;256(1):59-69. doi: 10.1007/s00417-017-3831-6. Epub 2017 Nov 8.

  PMID: 29119239 BACKGROUND

MeSH Terms

Conditions

Macular Edema

Interventions

Dexamethasone; Calcium Dobesilate; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2012
• First Posted: August 9, 2012
• Study Start: September 4, 2012
• Primary Completion: March 31, 2014
• Study Completion: May 20, 2014
• Last Updated: April 17, 2019
• Results First Posted: June 8, 2015

Record last verified: 2019-04

Locations

CN (1)