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CLINICAL TRIALS

The doctors at Oregon Retina, LLP are dedicated to bringing you the most advanced medical and surgical care available. As part of this commitment, our research team carefully selects and facilitates clinical trials that offer our patients exciting new options in the fight against retinal diseases, including diabetic macular edema (DME) and age-related macular degeneration (AMD).

ONGOING CLINICAL TRIALS

Diabetic Macular Edema

Protocol V (DRCRnet)
Treatment for central-involved Diabetic Macular Edema (DME) in eyes with very good visual acuity.

BOULEVARD (Roche)
A Randomized, Multicenter, Prospective, Phase II clinical trial comparing the efficacy of intravitreal RO6867461 at different doses vs. intravitreal Lucentis® (ranibizumab).

Wet Age-related Macular Degeneration

HAWK (Alcon)

A Two-Year, Randomized, Double-masked, Multicenter, Three-Arm study comparing the efficacy and safety of RTH258 versus aflibercept in subjects with neovascular Age-related Macular Degeneration (AMD).

AVENUE (Roche)

A Randomized, Multicenter, Prospective, Phase II clinical trial comparing the efficacy of intravitreal RO6867461 at different doses vs. intravitreal Lucentis® (ranibizumab).

STAIRWAY (Roche)

A Randomized, Multicenter, Prospective, Phase II clinical trial to investigate the efficacy of intravitreal RO6867461 administered with extended dosing regimens vs. intravitreal Lucentis® (ranibizumab).

 

Dry Age-related Macular Degeneration

BEACON (Allergan)

A safety and efficacy study of brimonidine intravitreal implant in Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD).

TOGA (University of Virginia)

A Randomized, Double-masked, Placebo-controlled study evaluating ORACEA® in subjects with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD).

CLG561 (Alcon)

A Randomized, Multicenter, Single-masked, Sham-controlled, Phase II clinical trial comparing the efficacy of intravitreal CLG561 as a monotherapy and in combination with LFG316 in patients with Geographic Atrophy.

ALA (University of Pennsylvania)

A Randomized, Double-masked, Placebo-controlled, Multicenter, Phase II clinical trial evaluating Alpha Lipoic Acid (ALA) as a treatment for Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD).

COMPLETED CLINICAL TRIALS

Symptomatic Vitreomacular Traction

Ocriplasmin Outcome Study

A Macula Society initiative for a Multicenter, Retrospective analysis of the safety and efficacy of JETREA® for the treatment of symptomatic VitreoMacular Traction (VMT) or Macula Holes (MH).

Non-Infectious, Posterior Uveitis

SAKURA (Santen)

A Phase III, Multinational, Multicenter, Randomized, Double-masked study for the treatment of active, non-infectious uveitis.

Here are the most common questions about our Clinical Trials.

CLICK ON THE QUESTIONS BELOW TO REVEAL THE ANSWER

WHAT IS A CLINICAL TRIAL?

A clinical trial is a study designed to answer a specific health question, usually regarding the safety and efficacy of a medical drug or intervention for the treatment of a specific health problem. These studies allow doctors to evaluate the benefits and risks of treatments. Ultimately, clinical trials exist to find safe, effective treatments that improve human health.

WHAT STUDIES ARE AVAILABLE?

To see if you qualify for any of our research opportunities, feel free to ask your physician. The doctor will work with you to determine the best potential available trial, if any.

HOW LONG WILL I BE IN A CLINICAL TRIAL?

The length of time a study lasts varies depending on what is being studied. Some studies require as little as a month of participation while others may expect you to participate for two years or more. The study-specific amount of time asked of you, as well as the study visit schedule, will be fully explained to you before you decide to enter. If you agree to participate in a study, we ask that you do your best to remain a participant for the planned duration of the study.

WHAT ARE THE RISKS OF CLINICAL TRIALS?

The research team at Oregon Retina, LLP closely examines all clinical trials and selects only those we determine are well-designed with solid scientific backing. The study participant’s health and safety is of prime importance. All risks that may be associated with the study will be discussed in detail before you decide to enter the trial. Study participants should expect to spend a slightly longer time in appointments because of the thorough testing required.

WILL MY INFORMATION BE KEPT PRIVATE?

We do our best to ensure that your information is kept private and secure. Your name will not be used in any papers, presentations or posters derived from a study’s data. In some cases, we may be required to reveal your information, such as if we are required by law.

DO I GET PAID TO PARTICIPATE IN CLINICAL TRIALS?

Most trials do not offer compensation to participants. The details of compensation for a study you qualify for will be discussed with you during the informed consent process.

WHY PARTICIPATE IN A CLINICAL TRIAL?

Clinical trials generally compare existing treatments, enhance existing treatments or investigate a new treatment option. There are many reasons people choose to participate in clinical studies:

  • Clinical trial participants have access to cutting-edge research before the general public.
  • Many treatments and services are provided at reduced or no-cost to study participants.
  • Clinical trials allow participants to help further the understanding of diseases and expand treatment options available to other patients.
WHAT WILL HAPPEN IF I DECIDE TO PARTICIPATE IN A CLINICAL TRIAL?

A consent form detailing the requirements, risks and benefits of the study will be provided to and reviewed with you by a member of the research team. Upon demonstrating your understanding of the consent form, as well as your willingness and ability to be in a research study, the consent form will be signed. Being a participant in a research study is completely voluntary and you can change your mind at any time, even if you have signed the consent form. After signing the consent form, you will be carefully screened to ensure that you match the criteria for the given study. This “screening visit” will likely be a separate appointment from your normal exam due to the standardized testing usually required in research.

CAN I STOP BEING IN A CLINICAL TRIAL?

Yes, you can decide to stop being in a study at any time. Inform a research staff member or your physician if you would like to end your participation. You may be asked to return for an early exit visit to close out your study participation. However, the benefits of research studies are greatest if you stay in the study for its entire duration. Your physician may also stop your participation in a study if he believes it is unsafe for you to continue, if the study is terminated, or if you are unable or unwilling to fulfill the obligations of the study.

HOW AM I PROTECTED AS A RESEARCH PARTICIPANT?

How am I protected as a research participant? The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) oversee many clinical trials in the US to protect the rights and welfare of clinical trial participants. In addition, all clinical trials involving human subjects are carefully reviewed by Institutional Review Boards (IRBs), which are responsible for ensuring that trials are conducted ethically and that study patient rights are protected.

WHO CAN I TALK TO ABOUT RESEARCH?

You can talk to the research doctors or staff if you have any questions regarding clinical trials.

FOR MORE INFORMATION

For more detailed information on participation in clinical trials, visit: ClinicalTrials.gov