A Prospective Study Comparing Ranibizumab Plus Dexamethasone Combination Therapy Versus Ranibizumab Monotherapy for Wet AMD

NCT00793923 | Completed Phase 1

• 1 other identifier: Lucedex
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this proposed research study is to evaluate the safety of intravitreal ranibizumab in combination with intravitreal dexamethasone in comparison to intravitreal ranibizumab alone in the treatment of wet ARMD. The addition of the broad spectrum anti-inflammatory activity of dexamethasone may augment the anti-VEGF activity of ranibizumab by amelioration of inflammation existing in the microenvironment of the choroidal neovascularization. While the anti-VEGF agents have proven to be very efficacious in the treatment of exudative ARMD, their narrow target and window of activity may limit their overall durability of action.

Conditions

Exudative Age-Related Macular Degeneration

Keywords

Exudative Age Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of ocular adverse events and visual acuity

  6 months and 12 months

Secondary Outcomes (1)

• Total number of treatments required

  12 months

Study Arms (2)

Combination Therapy

EXPERIMENTAL

Combination therapy (group 1): same day combination therapy with 0.05cc dose intravitreal dexamethasone injection (10mg/ml vial) and a single 0.5 mg intravitreal ranibizumab injection

Drug: ranibizumab and dexamethasone

Monotherapy

ACTIVE COMPARATOR

intravitreal injection of 0.5 mg ranibizumab

Drug: Ranibizumab

Interventions

ranibizumab and dexamethasone DRUG

Combination therapy (group 1): same day combination therapy with 0.05cc dose intravitreal dexamethasone injection (10mg/ml vial) and a single 0.5 mg intravitreal ranibizumab injection

Combination Therapy

Ranibizumab DRUG

intravitreal injection of 0.5 mg ranibizumab

Monotherapy

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Best Corrected Visual Acuity at 4 meters using ETDRS Charts between 20/32 and 20/400 (Snellen Equivalent) in the study eye with evidence of neovascular ARMD.
• (Only one eye will be eligible for study. If both eyes are eligible, the one with the better visual acuity will be selected for treatment unless, based on medical reasons, the investigator deems the other eye to be more appropriate for treatment and study.)
• All lesion subtypes will be enrolled with the following criteria Predominantly and minimally classic: Angiographic lesion greater than 50% of the total lesion area Occult: Lesions must show recent activity progression with respect to vision, subretinal hemorrhage or subretinal fluid
• Signed informed consent
• Age greater than or equal to 50 years

You may not qualify if:

• Previous treatment for ARMD in the study eye
• Previous intravitreal drug delivery in the study eye
• Previous vitrectomy in the study eye
• Fibrosis or atrophy involving the center of the fovea in the study eye
• Neovascular membrane from any other concurrent retinal disease such as high myopia (SER \> -8D), histoplasmosis or other ocular inflammatory disease.
• Known history of glaucoma and on more than one topical medication
• History of glaucoma filtering surgery in the study eye
• History of corneal transplant in the study eye
• Patients with active co-existing macular disease such as diabetic macular edema
• Active intraocular inflammation in the study eye
• History of allergy to fluorescein not amenable to treatment
• Pregnancy (positive pregnancy test) or lactation
• Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
• Inability to comply with study or follow up procedures

Sponsors & Collaborators

• Subhransu K. Ray, M.D., Ph.D.: lead
• Bay Area Retina Associates: collaborator

Study Sites (1)

Bay Area Retina Associates

Walnut Creek, California, 94598, United States

Location

MeSH Terms

Interventions

Ranibizumab; Dexamethasone

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Subhransu K Ray, M.D., Ph.D.

  Bay Area Retina Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 17, 2008
• First Posted: November 19, 2008
• Study Start: January 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 19, 2012

Record last verified: 2012-12

Locations

US (1)