Single Site, Masked, Randomized, Controlled Study to Assess Efficacy of Osurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Macular Edema Due to Central or Branch Retinal Vein Occlusion

NCT01085734 | Completed Phase 4 Results

• 1 other identifier: OA001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Comparative study to see if treating with Osurdex in addition to Avastin in patients with retinal vein occlusions helps increased visual acuity outcomes

Conditions

Retinal Vein Occlusions

Outcome Measures

Primary Outcomes (1)

• Change From Baseline Visual Acuity at 6 Months

  Visual Acuity was measured with ETDRS visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.

  6 months

Secondary Outcomes (2)

• Number of Injections Needed

  baseline to 6 months

• Change in Macular Thickness and Macular Volume

  6 months

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Group 1 receives Avastin at baseline followed by sham Osurdex at week 1. Additional Avastin based on macular edema

Drug: Avastin

Group 2

ACTIVE COMPARATOR

Group 2 receives Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin based on macular edema

Drug: Osurdex; Drug: Avastin

Interventions

Avastin DRUG

1.25mg intravitreally

Group 1

Osurdex DRUG

0.7mg intravitreally

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male or female age 18 years or older
• Branch retinal vein occlusion or central retinal vein occlusion of less than one year duration
• Best correct visual acuity of greater than 24 and less than 80
• Presence of macular edema defined as OCT central subfield thickness of \>250

You may not qualify if:

• intravitreal anti-VEGF treatment in study eye within six weeks of baseline
• intravitreal steroid treatment in the study eye within eight weeks of baseline visit
• PRP in the study eye within 4 month of baseline visit
• Active iris neovascularization in study eye
• Uncontrolled systemic disease
• Known history of IOP elevation in response to corticosteroid treatment that is not controlled on 2 glaucoma medications

Sponsors & Collaborators

• Maturi, Raj K., M.D., P.C.: lead

Study Sites (1)

Raj K. Maturi, MD

Indianapolis, Indiana, 46290, United States

Location

MeSH Terms

Conditions

Retinal Vein Occlusion

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Raj K. Maturi, MD
• Organization: Raj K. Maturi, MD, PC

rmaturi@gmail.com

317-817-1414

Study Officials

• Raj K Maturi, MD

  Raj K. Maturi, MD, PC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: March 10, 2010
• First Posted: March 12, 2010
• Study Start: March 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: April 21, 2014
• Results First Posted: April 21, 2014

Record last verified: 2014-03

Locations

US (1)