NCT03022292: IAI-OCTA

The IAI-OCTA Study; a Study of OCT-Angiography Analysis Efficacy

Completed Phase 4 Results posted Last updated 6 January 2022

What this trial tests

Phase 4 trial testing Aflibercept Ophthalmic in Wet Macular Degeneration in 26 participants. Completed in 31 August 2020.

Timeline

30 March 2017

Primary endpoint
25 June 2020

31 August 2020

Quick facts

Lead sponsor	University of California, Los Angeles
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	26
Start date	30 March 2017
Primary completion	25 June 2020
Estimated completion	31 August 2020
Sites	1 location across United States

Drugs / interventions tested

• Aflibercept Ophthalmic
• optovue angiovue

Conditions studied

• Wet Macular Degeneration — all drugs for Wet Macular Degeneration →

Sponsor

University of California, Los Angeles

Who can join

50 and older, any sex, with Wet Macular Degeneration. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Area of Lesion Measured by Optical Coherence Tomography Angiography (OCTA) Scan. Primary · Week 24

Area of the neovascular lesion (in millimeters\^2)

Group	Value	95% CI
IAI Treatment	1.07	0 – 9.939

Area of Lesion Measured by Optical Coherence Tomography Angiography (OCTA) Scan. Primary · Week 52

Area of the neovascular lesion (in millimeters\^2)

Group	Value	95% CI
IAI Treatment	0.67	0 – 6.056

Best Corrected Visual Acuity (BCVA) -Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Change Secondary · Baseline, Week 24

patients with gain of ≥5, ≥10, or ≥15 ETDRS letters. The ETDRS chart is read at 4.0 meters, and presents a series of five letters of equal difficulty on each row, with standardized spacing between letters and rows, for a total of 14 lines (70 letters).

≥5 ETDRS letters

Group	Value	95% CI
IAI Treatment	4

≥10 ETDRS letters

Group	Value	95% CI
IAI Treatment	2

≥15 ETDRS letters

Group	Value	95% CI
IAI Treatment	0

Best Corrected Visual Acuity (BCVA) -ETDRS Letter Change Secondary · Week 24, Week 52

patients with gain of ≥5, ≥10, or ≥15 ETDRS letters. The ETDRS chart is read at 4.0 meters, and presents a series of five letters of equal difficulty on each row, with standardized spacing between letters and rows, for a total of 14 lines (70 letters).

≥5 ETDRS letters

Group	Value	95% CI
IAI Treatment	4

≥10 ETDRS letters

Group	Value	95% CI
IAI Treatment	1

≥15 ETDRS letters

Group	Value	95% CI
IAI Treatment	0

Mean Best Corrected Visual Acuity (BCVA) Secondary · Week 24

Visual acuity (VA) was assessed at a distance of 4 meters from Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.

Group	Value	95% CI
IAI Treatment	0.3	-0.2 – 1.3

Mean Best Corrected Visual Acuity (BCVA) Secondary · Week 52

Visual acuity (VA) was assessed at a distance of 4 meters from Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.

Group	Value	95% CI
IAI Treatment	0.33	-0.2 – 1.2

OCTA Neovascular Membrane Regression Ratio of Change Secondary · 12 weeks

OCT angiography regression of neovascular membrane as measured by ratio of change in area of the neovascular lesion (in millimeters\^2) during the initial 12 weeks

Group	Value	95% CI
IAI Treatment	0.37	0.14 – 0.74

Presence of Intraretinal and Subretinal Fluid, and Subretinal Hyper-Reflective Material (SHRM) on Spectral Domain Optical Coherence Tomography (SD-OCT) Scan. Secondary · week 24

Participants with presence of intraretinal and subretinal fluid, and Subretinal Hyper-Reflective Material (SHRM)

intraretinal

Group	Value	95% CI
IAI Treatment	4

subretinal

Group	Value	95% CI
IAI Treatment	9

SHRM

Group	Value	95% CI
IAI Treatment	1

SD OCT Presence of Intraretinal and Subretinal Fluid, and Subretinal Hyper-Reflective Material (SHRM) Secondary · week 52

Participants with presence of SD OCT intraretinal and subretinal fluid, and Subretinal Hyper-Reflective Material (SHRM)

intraretinal

Group	Value	95% CI
IAI Treatment	3

subretinal

Group	Value	95% CI
IAI Treatment	6

SHRM

Group	Value	95% CI
IAI Treatment	0

Ocular AE Secondary · 52 weeks

ocular adverse events

Group	Value	95% CI
IAI Treatment	2

Relevant Systemic SAE Secondary · 52 weeks

relevant systemic serious adverse events

Group	Value	95% CI
IAI Treatment	1

Number of Injections Secondary · week 24

Group	Value	95% CI
IAI Treatment	25

Adverse events — posted to ClinicalTrials.gov

Time frame: 52 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

IAI Treatment

Serious: 1/26 (4%)

Deaths: 0/26

Serious adverse events (1 terms)

Reaction	System	IAI Treatment
Retinal detachment	Eye disorders	—

Other adverse events (2 terms — click to expand)

Reaction	System	IAI Treatment
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Pneumonia	Infections and infestations	—

Most-reported serious reactions: Retinal detachment.

Data from ClinicalTrials.gov NCT03022292 adverse events section.

Sponsor's own description

A study investigating the ability of OCTA imaging technology to identify and analyze untreated type 1, 2, and 3 neovascular membrane lesions in treatment naive patients with exudative macular degeneration, as well as investigating the ability of the OCTA imaging technology to evaluate the treatment outcomes of Intravitreal Aflibercept Injection in neovascular lesions associated with macular degeneration.

This study is utilizing a new, FDA approved, non-standard of care technology (OCT-Angiography by Optovue) to image and evaluate the treatment outcomes of using standard of care Intravitreal Aflibercept Injections for their approved use in patients diagnosed with neovascular AMD who are naive to previous Anti-VEGF therapies.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.