EAGLE: Evaluating Genotypes Using Intravitreal Aflibercep... | NCT02689518

NCT02689518

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Regeneron Pharmaceuticals	INDUSTRY

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment - On-Label	Other	On-label intravitreal aflibercept (Eylea) injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks (2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months	Drug: Intravitreal aflibercept injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intravitreal aflibercept injection	Drug	Intravitreal aflibercept injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks(2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anatomic Response	The primary endpoint in the study is the correlation of CFH, HTRA1, VEGFA, C3, TIMP3, APOE, CETP, LIPC, TGFBR1, CFI, and CFB allele frequencies and VEGA expression in lymphoblastoid cell lines with response to intravitreal aflibercept injection treatment, based on anatomic outcomes: Early response (at Month 3) - o On optical coherence tomography(SD-OCT) Reduction in central retinal thickness by ≥ 50%, OR Central retinal thickness <300 um, OR Absence of retinal fluid Later response (at Month 12) - o On SD-OCT Reduction in central retinal thickness by ≥ 50%, OR Central retinal thickness < 300 um, OR Absence of retinal fluid Poor response, defined as no reduction of fluid or central retinal thickness at Month 12.	12 Months

Secondary Outcomes

Measure	Description	Time Frame
Visual/Treatment Response	The secondary endpoints are a correlation of CFH, VEGF, HTRA1, VEGFA, C3, TIMP3, APOE, CETP, LIPC, TGFBR1, CFI, and CFB allele frequencies: With visual outcomes - Early response, defined as a gain ≥ 0 letters at Month 3 Later response, defined as a gain ≥ 0 letters at Month 12 Poor response, defined as loss of visual acuity (gain <0 letters) at Month 12 With change in characteristics on fluorescein angiography and fundus photography (lesion size, lesion type, etc) With number of injections through Month 12 o Mean number of intravitreal aflibercept injections required through Month 12 will be calculated for the group overall, and separately by response group (early, later, and no response to treatment).

Other Outcomes

Measure	Description	Time Frame
Safety - Incidence and Severity of Ocular and Non-ocular Adverse Events	Incidence and severity of ocular and non-ocular adverse events using Aflibercept intravitreal injections will also be evaluated.	12 Months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 50 years
Naïve neovascular wet-AMD (has not received treatment before)
Willing and able to comply with clinic visits and study-related procedures
Provide signed informed consent

Exclusion Criteria:

Previous therapy in study eye for AMD or other retinal disease which may be used in the treatment of AMD
Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye
Any concurrent intraocular condition in the study eye (e.g. diabetic retinopathy or glaucoma) that, in the opinion of the investigator, could either 4.1 require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition, or 4.2 if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the study period
Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye
Current vitreous hemorrhage in the study eye
History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
Aphakia, ACIOL, or unstable PCIOL
Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication)
Pregnant or breast-feeding women
Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly)
Any other condition that the investigator believes would pose a significant hazard to the patient if the investigational therapy were initiated *Contraception is not required for men with documented vasectomy. **Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.

Name	Affiliation	Role
Michael Goldbaum, M.D.	UCSD	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Shiley Eye Center		La Jolla	California	92126	United States

Arm/Group Information

ID	Title	Description
FG000	Treatment - On-Label	On-label intravitreal aflibercept (Eylea) injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks (2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months Intravitreal aflibercept injection: Intravitreal aflibercept injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks(2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Treatment - On-Label	On-label intravitreal aflibercept (Eylea) injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks (2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months Intravitreal aflibercept injection: Intravitreal aflibercept injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks(2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

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

Anatomic Response

The primary endpoint in the study is the correlation of CFH, HTRA1, VEGFA, C3, TIMP3, APOE, CETP, LIPC, TGFBR1, CFI, and CFB allele frequencies and VEGA expression in lymphoblastoid cell lines with response to intravitreal aflibercept injection treatment, based on anatomic outcomes:

Early response (at Month 3) - o On optical coherence tomography(SD-OCT)

Reduction in central retinal thickness by ≥ 50%, OR
Central retinal thickness <300 um, OR
Absence of retinal fluid

Later response (at Month 12) -

o On SD-OCT

Reduction in central retinal thickness by ≥ 50%, OR
Central retinal thickness < 300 um, OR
Absence of retinal fluid

Poor response, defined as no reduction of fluid or central retinal thickness at Month 12.

Principal Investigator is no longer associated with the institution. All efforts were exhausted to obtain the data but no data could be found.

Posted

12 Months

ID	Title	Description
OG000	Treatment - On-Label

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Treatment - On-Label	On-label intravitreal aflibercept (Eylea) injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks (2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months Intravitreal aflibercept injection: Intravitreal aflibercept injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks(2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months.

Title	Organization	Phone	Extension	Email
Professor Michael Goldbaum	University of California San Diego	858 534 3516		mgoldbaum@ucsd.edu

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 21, 2019	Feb 12, 2021	Prot_000.pdf

ID	Term
D008268	Macular Degeneration
D057135	Wet Macular Degeneration
D009389	Neovascularization, Pathologic
D012162	Retinal Degeneration

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D008679	Metaplasia
D010335	Pathologic Processes

ID	Term
C533178	aflibercept

On-label intravitreal aflibercept (Eylea) injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks (2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months

Intravitreal aflibercept injection: Intravitreal aflibercept injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks(2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months.