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The trial was stopped early due to insufficient study drug supply and study funding constraints
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A Phase 2 study to determine the safety and preliminary efficacy of intravitreal injections of AVD-104, a novel glyco-mimetic nanoparticle, in reducing macular edema associated with diabetic retinopathy.
The primary objective is to evaluate the tolerability and treatment effect of intravitreal injections (IVT) of AVD-104 in participants with diabetic macular edema (DME). Participants will receive either three intravitreal injections of low-dose AVD-104 (1.0 mg) each 28 days apart or two intravitreal injections of AVD-104 at a high-dose (2.0 mg) 56 days apart. Serial optical coherence tomography (OCT), ultra wide-field fluorescein angiography, and OCT-angiography (OCT-A) will be performed to evaluate the treatment effect on central subfield thickness (CST) and areas of non-perfusion. All participants will be followed-up for safety until day 84.
There will be a planned enrollment up to 30 participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose AVD-104 | Experimental | Three intravitreal injections at 1.0 milligram per eye each 28 days apart will be administered to the study eye. Participants will be followed for 84 days total. |
|
| High dose AVD-104 | Experimental | Two intravitreal injections at 2.0 milligrams per eye 56 days apart will be administered to the study eye. Participants will be followed for 84 days total. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVD-104 | Drug | An intravitreal injection of 50 microliters at the doses described will be given. Visual acuity, optical coherence tomography thickness and vascular perfusion will be evaluated for an effect of the drug. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Serious Adverse Events | Number of participants with any evidence of serious adverse events as assessed by ocular examination | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Effect | Evaluate the treatment effect of AVD-104 at multiple doses on central subfield thickness (CST) as measured by Spectral-domain optical coherence tomography (SD-OCT) | 3 months |
| Treatment Effect - Vision |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Callanan, MD | Aviceda Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erie Retina Research | Erie | Pennsylvania | 16507 | United States | ||
| Texas Retina Associates |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose AVD-104 | Three intravitreal injections at 1.0 milligram per eye each 28 days apart will be administered to the study eye. Participants will be followed for 84 days total. AVD-104: An intravitreal injection of 50 microliters at the doses described will be given. Visual acuity, optical coherence tomography thickness and vascular perfusion will be evaluated for an effect of the drug. |
| FG001 | High Dose AVD-104 | Two intravitreal injections at 2.0 milligrams per eye 56 days apart will be administered to the study eye. Participants will be followed for 84 days total. AVD-104: An intravitreal injection of 50 microliters at the doses described will be given. Visual acuity, optical coherence tomography thickness and vascular perfusion will be evaluated for an effect of the drug. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose AVD-104 | Three intravitreal injections at 1.0 milligram per eye each 28 days apart will be administered to the study eye. Participants will be followed for 84 days total. AVD-104: An intravitreal injection of 50 microliters at the doses described will be given. Visual acuity, optical coherence tomography thickness and vascular perfusion will be evaluated for an effect of the drug. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Serious Adverse Events | Number of participants with any evidence of serious adverse events as assessed by ocular examination | Posted | Count of Participants | Participants | 3 months |
|
The first participant was enrolled 11-30-2023 with last participant visit on 04-05-2024. The study was terminated early with only 7 participants followed for the planned 3 month followup period. 13 of the remaining participants were seen for an early close-out safety visit with 1 participant lost to followup.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Dose AVD-104 | Three intravitreal injections at 1.0 milligram per eye each 28 days apart will be administered to the study eye. Participants will be followed for 84 days total. AVD-104: An intravitreal injection of 50 microliters at the doses described will be given. Visual acuity, optical coherence tomography thickness and vascular perfusion will be evaluated for an effect of the drug. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual impairment | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Callanan | Aviceda Therapeutics | 817-312-9258 | dcallanan@avicedarx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 25, 2023 | Mar 30, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 10, 2024 | Mar 30, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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Evaluate the treatment effect of AVD-104 at multiple doses on Best-corrected visual acuity (BCVA) using ETDRS ((Early-Treatment Diabetic Retinopathy Study) visual acuity charts
| 3 months |
| Dallas |
| Texas |
| 75231 |
| United States |
| West Texas Retina Consultants | Wichita Falls | Texas | 76309 | United States |
| BG001 | High Dose AVD-104 | Two intravitreal injections at 2.0 milligrams per eye 56 days apart will be administered to the study eye. Participants will be followed for 84 days total. AVD-104: An intravitreal injection of 50 microliters at the doses described will be given. Visual acuity, optical coherence tomography thickness and vascular perfusion will be evaluated for an effect of the drug. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Treatment Effect | Evaluate the treatment effect of AVD-104 at multiple doses on central subfield thickness (CST) as measured by Spectral-domain optical coherence tomography (SD-OCT) | The trial was discontinued due to Intellectual property (IP) supply issues and study funding constraints. Only 6 participants received treatment with scheduled follow-up to 3 months and gradable SD-OCT. The planned treatment schedule for 30 participants was not achieved. | Posted | Mean | Standard Deviation | microns | 3 months |
|
|
|
| Secondary | Treatment Effect - Vision | Evaluate the treatment effect of AVD-104 at multiple doses on Best-corrected visual acuity (BCVA) using ETDRS ((Early-Treatment Diabetic Retinopathy Study) visual acuity charts | The trial was discontinued due to IP supply issues and study funding constraints. Only 6 participants received treatment up to 3 months of the planned 30 participants. 10 of the participants only received a single injection. This is a limited sample and the planned treatment schedule was not achieved. | Posted | Mean | Standard Deviation | ETDRS letters | 3 months |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 5 |
| 10 |
| EG001 | High Dose AVD-104 | Two intravitreal injections at 2.0 milligrams per eye 56 days apart will be administered to the study eye. Participants will be followed for 84 days total. AVD-104: An intravitreal injection of 50 microliters at the doses described will be given. Visual acuity, optical coherence tomography thickness and vascular perfusion will be evaluated for an effect of the drug. | 0 | 11 | 0 | 11 | 0 | 11 |
| Eye inflammation | Eye disorders | Systematic Assessment |
|
| Vitreous opacities | Eye disorders | Systematic Assessment |
|
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| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |