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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03944070
Other study ID # 2017/001_OPH-ECSAMD
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date January 2020

Study information

Verified date May 2019
Source Ophthalmica Eye Institute
Contact Paris G Tranos, PhD
Phone 00302310263063
Email tranos@ophthalmica.gr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To-date there have been only very few studies to examine the effect of cataract surgery to patients with wet age-related macular degeneration. The evidence on the effects of cataract surgery in such patients suggests improvement of their visual function and quality of life, but at the same time a subclinical susceptibility to macular edema and exacerbation of the choroidal neovascularization. Therefore it is highly important to identify the optimum treatment regime, pursuing the best anatomical and functional postoperative results.


Description:

To-date there have been only very few studies to examine the effect of cataract surgery to patients with neovascular age-related macular degeneration (AMD), especially in the era of anti-vascular endothelial growth factor (anti-VEGF) therapy. Furthermore the issue of optimum treatment regimen that should be used in the peroperative period has never been addressed. Since the human life expectancy gradually increases, the number of patients who are under anti-VEGF intravitreal injections for wet AMD will be increasing accordingly. Cataract surgery in such patients, despite guarded prognosis has been proved to improve their visual function and quality of life. On the other hand, it has been shown that cataract surgery induces anatomic changes based on optical coherence tomography analysis, suggesting a subclinical susceptibility to postoperative cystoid macular edema or exacerbation of choroidal neovascularization. Therefore it is highly important to identify the optimum treatment regime, pursuing the best anatomical and functional postoperative results.


Recruitment information / eligibility

Status Recruiting
Enrollment 16
Est. completion date January 2020
Est. primary completion date January 2020
Accepts healthy volunteers No
Gender All
Age group 50 Years to 99 Years
Eligibility Inclusion Criteria:

- Active choroidal neovascularization (at least 1 intravitreal injection in the past 12 months) associated with AMD and involving the foveal center

- BCVA of 1.0 (LogMAR) or better

- Duration of wet AMD less than 3 years

Exclusion Criteria:

- Coexisting ocular pathology potentially affecting visual acuity and/or status of the macula including diabetic retinopathy, advanced glaucoma, retinal vein occlusion, retinal detachment

- Newly diagnosed patients with wet AMD who are on anti-VEGF treatment for less than 6 months

Study Design


Intervention

Drug:
Ranibizumab
Intravitreal Ranibizumab is approved for the treatment of wet AMD. In this study we will compare an intensive injection protocol versus the standard treat and extend protocol in wet AMD patients undergoing cataract surgery.

Locations

Country Name City State
Greece Ophthalmica Eye Institute Thessaloníki Kalamaria

Sponsors (1)

Lead Sponsor Collaborator
Ophthalmica Eye Institute

Country where clinical trial is conducted

Greece, 

References & Publications (2)

Kessel L, Erngaard D, Flesner P, Andresen J, Tendal B, Hjortdal J. Cataract surgery and age-related macular degeneration. An evidence-based update. Acta Ophthalmol. 2015 Nov;93(7):593-600. doi: 10.1111/aos.12665. Epub 2015 Jan 20. Review. — View Citation

Saraf SS, Ryu CL, Ober MD. The effects of cataract surgery on patients with wet macular degeneration. Am J Ophthalmol. 2015 Sep;160(3):487-492.e1. doi: 10.1016/j.ajo.2015.06.006. Epub 2015 Jun 19. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Visual acuity change from baseline Difference in visual acuity change from baseline at the end of the follow-up period. 12 months
Primary Difference in the number of injections Difference in the number of injections at the end of the follow-up period. 12 months
Secondary Status of the macular degeneration based on optical coherence tomography parameter, as compared to baseline The status of the age-related macular degeneration will be evaluated based on optical coherence tomography parameters at the at final follow-up and compared to the baseline. Our main focus is to identify any subfoveal scarring and/ or subfoveal atrophy that may develop during the follow-up and assess changes from the baseline state of the macula. 12 months
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