Trial Outcomes & Findings for A Phase 2 Study of Intravitreal AVD-104 in Diabetic Macular Edema (NCT NCT06181227)

NCT ID: NCT06181227

Last Updated: 2025-07-14

Results Overview

Number of participants with any evidence of serious adverse events as assessed by ocular examination

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 21 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2025-07-14

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	10	11
Overall Study COMPLETED	3	2
Overall Study NOT COMPLETED	7	9

Reasons for withdrawal

Measure	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.	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.
Overall Study Study terminated by sponsor	7	9

Baseline Characteristics

A Phase 2 Study of Intravitreal AVD-104 in Diabetic Macular Edema

Baseline characteristics by cohort

Measure	Low Dose AVD-104 n=10 Participants 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.	High Dose AVD-104 n=11 Participants 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.	Total n=21 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age, Continuous	65.2 years STANDARD_DEVIATION 6.44 • n=5 Participants	66.6 years STANDARD_DEVIATION 11.14 • n=7 Participants	66.0 years STANDARD_DEVIATION 9.01 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · White	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	11 participants n=7 Participants	21 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Number of participants with any evidence of serious adverse events as assessed by ocular examination

Outcome measures

Measure	Low Dose AVD-104 n=10 Participants 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.	High Dose AVD-104 n=11 Participants 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.
Incidence of Serious Adverse Events	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 3 months

Population: 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.

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)

Outcome measures

Measure	Low Dose AVD-104 n=2 Participants 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.	High Dose AVD-104 n=4 Participants 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.
Treatment Effect Baseline	653.5 microns Standard Deviation 116.7	432.0 microns Standard Deviation 111.8
Treatment Effect Month 3	803.5 microns Standard Deviation 10.6	560.3 microns Standard Deviation 254.1

SECONDARY outcome

Timeframe: 3 months

Population: 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.

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

Outcome measures

Measure	Low Dose AVD-104 n=2 Participants 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.	High Dose AVD-104 n=4 Participants 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.
Treatment Effect - Vision Baseline	52 ETDRS letters Standard Deviation 11.3	67 ETDRS letters Standard Deviation 9.8
Treatment Effect - Vision Month 3	25.5 ETDRS letters Standard Deviation 0.7	68 ETDRS letters Standard Deviation 16.3

Adverse Events

Low Dose AVD-104

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

High Dose AVD-104

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Low Dose AVD-104 n=10 participants at risk 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.	High Dose AVD-104 n=11 participants at risk 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.
Eye disorders Visual impairment	20.0% 2/10 • Number of events 2 • 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.	0.00% 0/11 • 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.
Eye disorders Eye inflammation	20.0% 2/10 • Number of events 3 • 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.	0.00% 0/11 • 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.
Eye disorders Vitreous opacities	20.0% 2/10 • Number of events 2 • 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.	0.00% 0/11 • 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.

Additional Information

David Callanan

Aviceda Therapeutics

Phone: 817-312-9258

Email: dcallanan@avicedarx.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60