MedDataX Logo

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

NCT ID: NCT00793923

Last Updated: 2012-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A prospective, single masked comparative trial using either combination therapy (group 1): same day combination therapy with 0.05cc intravitreal dexamethasone injection (10mg/ml vial) and a single 0.5 mg intravitreal ranibizumab injection for four consecutive months will be compared to monotherapy (group 2): one intravitreal injection of 0.5 mg ranibizumab also given for four consecutive months. These treatments will then be followed by PRN treatment based on clinical exam, angiographic studies, and OCT evidence of residual subretinal fluid, CME, subretinal hemorrhage, or pigment epithelial detachment. Fluorescein angiography and fundus photography will be performed at baseline and at the 1, 3, 6, and 12 month follow-up visits. Only OCT testing will be performed at all follow-up visits. Both groups will be re-evaluated for safety at 12 and 24 months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Exudative Age-Related Macular Degeneration

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Exudative Age Related Macular Degeneration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Combination Therapy

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

Group Type EXPERIMENTAL

ranibizumab and dexamethasone

Intervention Type 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

Monotherapy

intravitreal injection of 0.5 mg ranibizumab

Group Type ACTIVE_COMPARATOR

Ranibizumab

Intervention Type DRUG

intravitreal injection of 0.5 mg ranibizumab

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ranibizumab and dexamethasone

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

Intervention Type DRUG

Ranibizumab

intravitreal injection of 0.5 mg ranibizumab

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

• 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

Exclusion Criteria

* 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
* Participation in another simultaneous medical investigation or trial
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bay Area Retina Associates

OTHER

Sponsor Role collaborator

Subhransu K. Ray, M.D., Ph.D.

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Subhransu K. Ray, M.D., Ph.D.

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Subhransu K Ray, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Bay Area Retina Associates

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bay Area Retina Associates

Walnut Creek, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Lucedex

Identifier Type: -

Identifier Source: org_study_id