Octreotide for Diabetic Macular Edema

Overseen By Nicholas Medawar, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Alabama at Birmingham

Must not be taking: Anti-inflammatories, COX-2 inhibitors, Statins

Disqualifiers: Diabetes, Hypertension, Autoimmune, Cancer, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new form of the drug octreotide, administered as a nasal spray, can treat diabetic macular edema. Diabetic macular edema, an eye condition in people with diabetes, can lead to vision problems. Current treatments are not effective for everyone, so this study tests a new method for those who haven't found success with existing options. Individuals diagnosed with diabetic retinopathy and diabetic macular edema, who have not responded to other treatments, might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new form of treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as anti-inflammatory drugs, COX-2 inhibitors, and certain statins, before and during the study. If you are currently on these medications, you may need to stop them to participate.

Is there any evidence suggesting that octreotide is likely to be safe for humans?

Research has shown that octreotide, a type of medication, is generally safe. Studies on its long-acting form have found a low risk of serious side effects, particularly concerning heart problems. This finding is encouraging for its potential use in treating diabetic macular edema (DME). The current trial tests octreotide in a new way, using a nasal spray. While this method remains under study, existing research on octreotide offers some confidence in its safety for participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Octreotide is unique because it targets diabetic macular edema using an intranasal delivery method, which is a departure from the usual eye injections or laser treatments. This approach could make treatment more convenient and less invasive for patients. Additionally, octreotide works by mimicking a natural hormone that can help reduce fluid buildup in the eye, potentially offering a new mechanism of action compared to traditional treatments like anti-VEGF injections. Researchers are excited about its potential to offer a more patient-friendly alternative with fewer side effects.

What evidence suggests that octreotide might be an effective treatment for diabetic macular edema?

Research has shown that octreotide, a drug similar to somatostatin, may help treat various types of macular edema, a condition causing swelling in the eye. One study found that octreotide improved or completely resolved macular edema in 7 out of 9 eyes. This finding suggests it might also be effective for diabetic macular edema. In this trial, participants in the Octreotide Arm will receive the investigational drug, DDM-Octreotide, administered intranasally. Octreotide is generally well-tolerated, with long-term studies indicating its safety. Early research suggests that delivering octreotide through the nose might also improve vision and reduce eye swelling. These promising results indicate octreotide could be an option for those who haven't found relief with other treatments. ^{1 2 3 4 5}

Who Is on the Research Team?

Maria Grant, MD, FARVO

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for individuals with diabetic macular edema who haven't responded well to standard treatments like anti-VEGF therapy. Participants should have a diagnosis of this condition and be looking for alternative treatment options.

Inclusion Criteria

Written informed consent is provided

Routine laboratory study results with bilirubin, aspartate aminotransferase and/or alanine aminotransferase, and creatinine within normal limits

I am either male or female.

Exclusion Criteria

Patients with a history of intolerance or hypersensitivity to octreotide or use of octreotide in the preceding 2 months

History of recent alcohol or drug abuse or noncompliance with treatment or other experimental protocols

All women of childbearing potential must have a negative urine pregnancy test at the Screening Visit and throughout the study. Sexually active women participating in the study must use a medically acceptable form of contraception

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intranasal DDM-Octreotide or placebo three times a day

4 weeks

Weekly visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Octreotide

Trial Overview The study tests if intranasal octreotide, which is usually given by injection under the skin, can help treat diabetic macular edema when other treatments fail. Some participants will receive a placebo instead to compare results.

How Is the Trial Designed?

Group I: Octreotide Arm Active Control 1 Intervention

Participants will receive the investigational drug, DDM-Octreotide, and administering intranasally in one nostril three times a day.

Group II: Control Group Placebo Group 1 Intervention

The control group will receive a placebo nasal spray without the active ingredient, DDM-octreotide, and administering intranasally in one nostril three times a day.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Stratum Medical

Collaborator

Trials

1

Recruited

60+

Published Research Related to This Trial

A new prolonged formulation of lanreotide, administered through monthly subcutaneous injections, shows promise as an effective treatment for patients with poorly controlled diabetes and persistent cystoid macular edema.

This treatment offers a potential alternative for managing diffuse diabetic macular edema, which typically does not respond well to conventional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lanreotide Autogel for persistent diabetic macular edema. Hernaez-Ortega, MC., Soto-Pedre, E., Piniés, JA.[2016]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06881888

Intranasal Delivery of Octreotide for Treatment of Diabetic ... This study thus seeks to determine the efficacy and safety of intranasal DDM-octreotide in the treatment of diabetic macula edema.

2. jamanetwork.com jamanetwork.com/journals/jamaophthalmology/fullarticle/417858

Octreotide as a Treatment for Uveitic Cystoid Macular Edema Octreotide treatment resulted in marked improvement or complete resolution of CME in 7 of 9 eyes (Figure 1 and Figure 2).

3. withpower.com withpower.com/trial/phase-1-edema-4-2025-8a6e6

Octreotide for Diabetic Macular Edema · Info for Participants Research shows that octreotide, a drug similar to somatostatin, has been effective in treating other types of macular edema, such as those caused by surgery and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5845597/

Long-term safety of long-acting octreotide in patients with ... The results from these long-term placebo-controlled studies confirm the established safety profile of long-acting OCT, in particular low risk of cardiac, ...

5. app.trialscreen.org app.trialscreen.org/trials/phase-1-intranasal-delivery-octreotide-treatment-diabetic-macular-edema-trial-nct06881888

Intranasal Delivery of Octreotide for Treatment of Diabetic ... Participants may benefit from improved vision and reduced macular edema if the intranasal octreotide treatment is effective. Additionally, the study findings ...