Evaluation of Pain and Inflammation After Injection of Lucentis vs Eylea for Treatment of Wet Macular Degeneration

NCT01926977 | Completed Phase 1 Results

• 2 other identifiers: ML2889520131227
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to compare the post injection inflammation and pain seen after intravitreal injections of Ranibizumab vs Aflibercept.

Conditions

Neovascular Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Evidence of Anterior Chamber Inflammation

  Evidence of anterior chamber inflammation at visit #1 and #2 using Standardization of Uveitis Nomenclature (SUN)

  24 to 48 hours (visit #1) and 5 to 7 days (visit #2)

Secondary Outcomes (1)

• Patients With Post Injection Pain Score of One or Higher on Pain Scale

  24 to 48 hours (visit #1) and 5 to 7 days (visit #2)

Study Arms (2)

Ranibizumab 0.5mg Intravitreal injection

ACTIVE COMPARATOR

Intravitreal injection of Ranibizumab 0.5mg once

Drug: Ranibizumab 0.5mg

Aflibercept 2.0mg Intravitreal injection

ACTIVE COMPARATOR

Intravitreal Aflibercept 2.0mg once

Drug: Aflibercept 2.0mg

Interventions

Ranibizumab 0.5mg DRUG

Patient will receive intravitreal injection of Ranibizumab 0.5mg.

Also known as: Lucentis

Ranibizumab 0.5mg Intravitreal injection

Aflibercept 2.0mg DRUG

Patients will receive intravitreal injection of Aflibercept 2.0mg.

Also known as: Eylea

Aflibercept 2.0mg Intravitreal injection

Eligibility Criteria

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

You may qualify if:

• Able to provide informed consent and comply with study assessments for the full duration of the study
• Age \>/= 65 years
• New onset Neovascular Age-Related Macular Degeneration or (See No.4)
• Previously treated Neovascular Age-Related Macular Degeneration with Lucentis or Eylea intravitreal injections
• Visual Acuity of 20/400 or better
• No history of Post injection pain or inflammation with prior treatments -

You may not qualify if:

• History of Endophthalmitis in either eye
• Uncontrolled or symptomatic Dry Eye Syndrome
• History of Anterior or Posterior Uveitis
• History of Post injection pain or inflammation with prior treatments
• Recent thromboembolic event(\<3 months)
• Pregnancy(positive pregnancy test) or Lactation/Premenopausal women not using adequate contraception -

Sponsors & Collaborators

• Arshad Khanani: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

MeSH Terms

Interventions

Ranibizumab; aflibercept

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Small sample size. Non-randomized choice of medications.

Results Point of Contact

• Title: Arshad Khanani M.D., Vitreo-Retinal Diseases and Surgery
• Organization: Sierra Eye Associates

arshad.khanani@gmail.com

775-329-0286

Study Officials

• Arshad M Khanani, MD

  Sierra Eye Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vitreo-Retinal Surgeon

Study Record Dates

• First Submitted: August 19, 2013
• First Posted: August 21, 2013
• Study Start: September 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: March 3, 2016
• Results First Posted: March 3, 2016

Record last verified: 2016-02

Locations

US (1)