What side effects are associated with this type of intervention?

Common treatments for diabetic retinopathy include laser therapy, anti-VEGF injections, and corticosteroids. Laser therapy can cause side effects such as mild vision loss, reduced peripheral and night vision. Anti-VEGF injections may lead to eye pain, floaters, and increased intraocular pressure. Corticosteroids can result in cataracts and elevated intraocular pressure, potentially leading to glaucoma. These treatments aim to prevent further vision loss and are often part of care protocols that patient navigator interventions seek to improve adherence to.

What prior FDA approvals exist?

The FDA has approved several treatments for Diabetic Retinopathy, including anti-VEGF injections like ranibizumab (Lucentis) and aflibercept (Eylea), which help reduce vision loss by inhibiting abnormal blood vessel growth. Additionally, corticosteroids such as dexamethasone implants (Ozurdex) are used to reduce inflammation. While these treatments focus on the medical management of the condition, interventions like the Patient Navigator program aim to improve patient engagement and adherence to care protocols, ensuring timely follow-ups and better overall management of the disease.

What other types of research exist?

Promising alternatives to Patient Navigator Intervention for Diabetic Retinopathy patients include telemedicine for remote monitoring and consultations, advanced imaging techniques like Optical Coherence Tomography Angiography (OCTA) for precise monitoring, and personalized treatment plans using data from recent clinical trials.

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Patient Navigation for Diabetic Retinopathy (SEEN Trial)

N/A

Waitlist Available

Led By Kristen Nwanyanwu, MD, MHS

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of diabetes and record of diagnosis in YNHHS EPIC

Be older than 18 years old

Must not have

Not high risk for diabetic retinopathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a program to help people with diabetes who are at high risk of going blind. The program will guide these patients to ensure they get the necessary eye exams. The goal is to improve screening rates and prevent blindness, especially in minority and low-income communities.

Who is the study for?

This trial is for English-speaking adults over 18 with diabetes, who haven't had an eye exam in the past year and are at high risk for diabetic retinopathy according to a risk calculator. They must have their diabetes diagnosis recorded in YNHHS EPIC.

What is being tested?

The study is testing a patient navigator program designed to help people with diabetes avoid blindness from diabetic retinopathy. It's a pilot study to see if this approach is practical and well-received before moving on to a larger clinical trial.

What are the potential side effects?

Since this intervention involves guidance rather than medication, there aren't typical drug side effects. However, participants may experience stress or anxiety related to managing their condition more closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with diabetes, and it is recorded in the YNHHS EPIC system.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not at high risk for vision problems due to diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participant who had baseline eye exam

Number of participants who completed a follow-up eye exam 12+ months after baseline eye exam

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intervention armExperimental Treatment1 Intervention

Intervention consists of standard of care eye exam and enrollment in a patient navigation program.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Patient Navigation

2017

Completed Phase 2

~38910

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Diabetic Retinopathy include anti-VEGF injections, laser therapy, and corticosteroids. Anti-VEGF injections work by inhibiting vascular endothelial growth factor, reducing abnormal blood vessel growth and leakage. Laser therapy seals leaking blood vessels and prevents the growth of new ones. Corticosteroids reduce inflammation and edema in the retina. These treatments are crucial as they help preserve vision and prevent further retinal damage. The Patient Navigator Intervention aims to improve patient engagement and adherence to these treatments, ensuring better management of the condition and potentially better outcomes.

Clinical trials: where do we go from here?Current landscape of type 1 diabetes mellitus-related interventional clinical trials registered on ClinicalTrials.gov: a cross-sectional study.The Effectiveness of Pharmacological Agents for the Treatment of Uveitic Macular Edema (UMO): A Systematic Review.