EAGLE: Evaluating Genotypes Using Intravitreal Aflibercept Injection

Macular Degeneration Clinical Trial

— EAGLE  

Official title:

Clinical and Genetic Assessment of Treatment Response in Patients With Age-related Macular Degeneration Using Intravitreal Aflibercept Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02689518
• Other study ID #: EAGLE
• Status: Completed
• Phase: Phase 4
• Start date: April 2014
• Est. completion date: November 12, 2019

Study information

• Verified date: March 2021
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Clinical and genetic evaluation of individuals treated with intravitreal aflibercept injection (Eylea) for neovascular age-related macular degeneration (wet AMD)

Description:

Clinical and genetic assessment of treatment response in patients with age-related macular degeneration using intravitreal aflibercept injection. This study seeks to determine if different genetic polymorphisms of vascular endothelial growth factor A (VEGF-A) and HtrA serine peptidase 1(HTRA1) and other genes correlate to the response to intravitreal aflibercept injection therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 12, 2019
• Est. primary completion date: November 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Age = 50 years

2. Naïve neovascular wet-AMD (has not received treatment before)

3. Willing and able to comply with clinic visits and study-related procedures

4. Provide signed informed consent

Exclusion Criteria:

1. Previous therapy in study eye for AMD or other retinal disease which may be used in the treatment of AMD

2. Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye

3. History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye

4. 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

5. Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye

6. Current vitreous hemorrhage in the study eye

7. History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye

8. Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye

9. Aphakia, ACIOL, or unstable PCIOL

10. Uncontrolled glaucoma in the study eye (defined as intraocular pressure =30 mmHg despite treatment with anti-glaucoma medication)

11. Pregnant or breast-feeding women

12. 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)

13. 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.

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Shiley Eye Center	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
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.	12 Months
Secondary	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).	12 Months