Management of Patients With Neovascular Age-related Macular Degeneration Undergoing Cataract Surgery

Ophthalmica Eye Institute

Status: Unknown

Conditions: Cataract Extraction; Wet Macular Degeneration

Treatments: Drug: Ranibizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT03944070

2017/001_OPH-ECSAMD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 50 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Intensive Treatment

Active Comparator group

Description:

The participants will receive x1 intraoperative and 3 postop monthly injections. Subsequently, they will follow the treat and extend protocol.

Treatment:

Drug: Ranibizumab

Standard Treatment

Active Comparator group

Description:

The participants will continue their preoperative treat and extend protocol .

Treatment:

Drug: Ranibizumab