Diabetic Macular EdemaPhase 1NCT06881888
Intranasal Delivery of Octreotide for Treatment of Diabetic Macular Edema
A Phase 1 study testing Octreotide (drug) in people with Diabetic Macular Edema, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Octreotide (drug)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2026to 8 Oct 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range 18-90
- Clinical diagnosis of diabetic retinopathy with diabetic macular edema (defined as CST greater than 250 and presence of microglia/macrophages on OCT) with a visual acuity between 20/32 and 20/200.
- Written informed consent is provided.
- Males and females
- Routine laboratory study results with bilirubin, aspartate aminotransferase and/or alanine aminotransferase, and creatinine within normal limits.
Who cannot join
- History of difficult to control diabetes or hypertension
- Eyes receiving laser photocoagulation in the last 6 months or intravitreous treatment for diabetic macular edema in the past 3 months.
- Eye having undergone YAG capsulotomy in the last 3 months.
- Having other ocular surgeries in the last 6 months (examples include but not limited to cataract surgery, scleral buckle, trabeculectomies, etc.).
- 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.
- Chronic infectious disease (e.g. HIV, HCV)
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- Positive urine β-hCG test day of visit or a serum beta-HCG test within 48 hours prior to the administration of intranasal octreotide.
- Other ocular diseases or fundus diseases
- Patients with a history of intolerance or hypersensitivity to octreotide or use of octreotide in the preceding 2 months.
- Currently taking an anti-inflammatory medication (e.g. anti-inflammatory agents, glucocorticoids or other immune modulating medications);
- Use of cyclooxygenase-2 (COX-2) inhibitors for < 6 months prior to study entry or dose changes after study entry. Limited as-needed use is permitted prior to study entry but not during the study.
- Use of statins that cross the blood brain barrier such as atorvastatin will not be permitted during the study as they have been shown to reduce levels of pro-inflammatory cytokines.
- Any degree of hepatic or renal insufficiency that in the Investigator's judgement would pose a safety risk for treatment with octreotide.
- Patients who based on history or mental status examination have a significant risk of committing suicide, or who are homicidal or violent and who are in the Investigator's opinion in significant imminent risk of hurting others.
- Patients who have a medical condition that, in the Investigator's opinion, would expose them to an increased risk of a significant adverse event or interfere with assessments of safety and efficacy during the course of the trial.
- Patients with a current known infection or who are acutely ill.
- Patients with an autoimmune disease (i.e., Lupus, Rheumatoid Arthritis).
- Patients with thyroid disorders unless euthyroid at screening.
- Patients with cancer not in remission.
- Inability to tolerate or intranasal administration of investigated drug and experiences severe irritation or sneezing.
- Inability to attend scheduled study visits, plans for family relocation during the study, or any other criteria that the investigator may determine to be associated with inability to complete the study.
- Limited mental capacity rendering the subject unable to provide written informed consent or comply with evaluation procedures.
- History of recent alcohol or drug abuse or noncompliance with treatment or other experimental protocols.
- Use of any investigational drug within 30 days prior to the baseline visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Alabama at Birmingham
Birmingham, Alabama, 35243
About this study
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.
- Conditions
- Diabetic Macular Edema
- Being tested
- Octreotide (drug), Placebo
- Keywords
- Diabetic Macular Edema, Intranasal Octreotide, Octreotide, Diabetic Retinopathy
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octreotide (drug)Drug
Also called Octreotide and 1-O-n-Dodecyl-b-D-Maltoyranoside (DDM) (Intravail®)
Participants will administer the DDM-octreotide nasal spray without priming in one nostril three times a day.
PlaceboDrug
Participants will administer the placebo nasal spray without priming in one nostril three times a day.
| Study group | Role | What they receive |
|---|---|---|
| Octreotide Arm | Active comparator | Participants will receive the investigational drug, DDM-Octreotide, and administering intranasally in one nostril three times a day. Receives: Drug: Octreotide (drug) |
| Control Group | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in macular central subfield thickness
Participants will have an optical coherence tomography at each visit that will measure macular central subfield thickness. Measuring the change at their baseline appointment and each additional study visit.
Measured: Up to one month.
Change in best corrected visual acuity
Each participant will have best corrected visual acuity measured by Early Treatment of Diabetic Retinopathy study (ETDRS) chart. Enter the full scale.
Measured: Up to one month.
Change in microglia on retinal surface
Each participant will have an optical coherence tomography angiography scan measuring the quantity of microglia on the retinal surface.
Measured: Up to one month
Changes in retinal peripheral capillary free zone
Each participant will have optical coherence tomography angiography and measure differences in retinal peripheral capillary free zone.
Measured: up to one month
Changes in retinal foveal avascular zone
Each participant will have optical coherence tomography angiography and measure differences in retinal foveal avascular zone.
Measured: up to one month
Changes in retinal capillary density
Each participant will have optical coherence tomography angiography and measure differences in retinal capillary density.
Measured: up to one month
Changes in retinal non-perfusion zones
Each participant will have optical coherence tomography angiography and measure differences in retinal non-perfusion zones.
Measured: up to one month
Secondary outcomes (1)
Changes in serum insulin like growth factor -1 (IGF-1) levels
Each participant will have serum IGF-1 levels measured.
Measured: up to one month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start31 Aug 2026 (estimated)
- Primary completion8 Oct 2026
- Study completion8 Oct 2026
Why it stopped: Project terminated due to loss of sponsor funding following the dissolution of AMD Opti.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Grant, University of Alabama at Birmingham
- Investigators
- Maria Grant, MD, FARVO, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881888
- Sponsor's protocol ID
- IRB-300011278
- Status last verified
- Oct 2026
- First submitted
- 5 Mar 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Delivery of Octreotide for Treatment of Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT06881888
- Acronym / sponsor ID
- IRB-300011278
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic Macular Edema, Intranasal Octreotide, Octreotide, Diabetic Retinopathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Project terminated due to loss of sponsor funding following the dissolution of AMD Opti.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 8 Oct 2026 (actual)
- Study completion
- 8 Oct 2026 (actual)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Octreotide Arm | Active comparator | Drug: Octreotide (drug)Participants will receive the investigational drug, DDM-Octreotide, and administering intranasally in one nostril three times a day. |
| Control Group | Placebo comparator | Drug: PlaceboThe 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 may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age range 18-90
- Clinical diagnosis of diabetic retinopathy with diabetic macular edema (defined as CST greater than 250 and presence of microglia/macrophages on OCT) with a visual acuity between 20/32 and 20/200.
- Written informed consent is provided.
- Males and females
- Routine laboratory study results with bilirubin, aspartate aminotransferase and/or alanine aminotransferase, and creatinine within normal limits.
Key exclusion criteria (24 listed)
- History of difficult to control diabetes or hypertension
- Eyes receiving laser photocoagulation in the last 6 months or intravitreous treatment for diabetic macular edema in the past 3 months.
- Eye having undergone YAG capsulotomy in the last 3 months.
- Having other ocular surgeries in the last 6 months (examples include but not limited to cataract surgery, scleral buckle, trabeculectomies, etc.).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Octreotide (drug)Also: Octreotide and 1-O-n-Dodecyl-b-D-Maltoyranoside (DDM) (Intravail®)Participants will administer the DDM-octreotide nasal spray without priming in one nostril three times a day. | Drug | Octreotide Arm |
| PlaceboParticipants will administer the placebo nasal spray without priming in one nostril three times a day. | Drug | Control Group |
Primary outcome
Change in macular central subfield thickness
Time frame: Up to one month.
Participants will have an optical coherence tomography at each visit that will measure macular central subfield thickness. Measuring the change at their baseline appointment and each additional study visit.
Change in best corrected visual acuity
Time frame: Up to one month.
Each participant will have best corrected visual acuity measured by Early Treatment of Diabetic Retinopathy study (ETDRS) chart. Enter the full scale.
Change in microglia on retinal surface
Time frame: Up to one month
Each participant will have an optical coherence tomography angiography scan measuring the quantity of microglia on the retinal surface.
Changes in retinal peripheral capillary free zone
Time frame: up to one month
Each participant will have optical coherence tomography angiography and measure differences in retinal peripheral capillary free zone.
Changes in retinal foveal avascular zone
Time frame: up to one month
Each participant will have optical coherence tomography angiography and measure differences in retinal foveal avascular zone.
Changes in retinal capillary density
Time frame: up to one month
Each participant will have optical coherence tomography angiography and measure differences in retinal capillary density.
Changes in retinal non-perfusion zones
Time frame: up to one month
Each participant will have optical coherence tomography angiography and measure differences in retinal non-perfusion zones.
1 secondary outcome
Changes in serum insulin like growth factor -1 (IGF-1) levels
Time frame: up to one month.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Grant, MD, FARVO principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Octreotide (drug) in people with Diabetic Macular Edema, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in macular central subfield thickness (time frame: Up to one month.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.