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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

Treatment of diabetic retinopathy (DR) and diabetic macula edema has included panretinal photocoagulation and intra ocular injections of anti-vascular endothelial growth factors (anti-VEGF) agents and steroids. Anti-VEGF therapy is currently the first-line treatment for proliferative diabetic retinopathies; however, this approach is ineffective in more than 30% of patients with diabetic retinal complications. Available evidence shows that subcutaneous (under the skin) injection of octreotide, a somatostatin analog, has potential therapeutic benefits in proliferative diabetic retinopathy (PDR) and diabetic macula edema (DME). This study thus seeks to determine the efficacy and safety of intranasal DDM-octreotide in the treatment of diabetic macula edema in individuals that are considered to be refractory to the current therapeutic options.

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.

What data supports the effectiveness of the drug Octreotide for treating diabetic macular edema?

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 uveitis (eye inflammation). Additionally, a similar drug, lanreotide, has shown promise in treating diabetic macular edema, suggesting octreotide might also be effective. ^{1 2 3 4 5}

How does the drug Octreotide differ from other treatments for diabetic macular edema?

Octreotide is unique because it is a somatostatin analog, which means it mimics a hormone that can help reduce fluid accumulation in the eye, unlike the more common treatments like anti-VEGF drugs or corticosteroids. It is administered as a long-acting injection, which may offer a different dosing schedule compared to other treatments that require more frequent administration. ^{1 2 4 6 7}

Research Team

Maria Grant, MD, FARVO

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A randomized, double-masked controlled clinical trial of Sandostatin long-acting release depot in patients with postsurgical cystoid macular edema. [2013]

2. Ireland pubmed.ncbi.nlm.nih.gov

Lanreotide Autogel for persistent diabetic macular edema. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

The efficacy of octreotide in the therapy of severe nonproliferative and early proliferative diabetic retinopathy: a randomized controlled study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Octreotide long-acting repeatable for the treatment of chronic macular edema in uveitis. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Macular function after intravitreal triamcinolone acetonide injection for diabetic macular oedema. [2013]

6. China pubmed.ncbi.nlm.nih.gov

An updated review of long-term outcomes from randomized controlled trials in approved pharmaceuticals for diabetic macular edema. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Evaluation of 0.2 µg/day fluocinolone acetonide (ILUVIEN) implant in a cohort of previously treated patients with diabetic macular oedema (DMO): a 36-month follow-up clinical case series. [2022]