Combined Therapy in Age-Related Macular Degeneration (ARMD)

Study Overview
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Brief Summary
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The purpose of this study is to investigate the efficacy of combined intravitreal therapy with or without prior photodynamic therapy in patients with wet age-related macular degeneration (AMD). In patients with wet AMD, a significant improvement in vision was observed after combined intravitreal therapy with or without prior photodynamic therapy. Both the pharmacological effects of the drugs and the physiological effects of the pars plana vitrectomy (posterior vitreous detachment, liquefaction, and oxygen redistribution) may have contributed to the long-term sustainability of the therapeutic benefits.

Detailed Description
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This prospective study of a case series included eyes with predominantly classic lesions (Group 1; n = 52) and eyes with occult lesions (Group 2; n = 106). Patients with predominantly classic lesions received low fluorescence photodynamic therapy (42 J/cm2 for 72 sec), followed by, 24 hours later, a 1.5 mL core pars plana vitrectomy with intravitreal injection of dexamethasone (0.8 mg) and bevacizumab (1.25 mg). Patients with occult lesions received a 0.4 mL core pars plana vitrectomy with intravitreal injection of triamcinolone (8 mg) and bevacizumab (1.25 mg). At baseline and follow-up examinations, the best-corrected visual acuity (BCVA; logMar), central macular thickness (optical coherence tomography), intraocular pressure (IOP; Goldmann tonometry) were determined. In addition, the need for retreatment was assessed, and adverse events were monitored.

Official Title
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Combined Therapy in ARMD - Retrospective Case Series

Conditions
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Age-Related Macular Degeneration

Intervention / Treatment
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* Procedure: Low fluorescence Photodynamic therapy
* Procedure: core pars plana vitrectomy
* Drug: dexamethasone
* Drug: bevacizumab
* Procedure: core pars plana vitrectomy
* Drug: triamcincolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Wet age related macular degeneration Exclusion Criteria: Opacities in lens or cornea Ongoing intraocular inflammation Trauma
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>eyes with predominately classic lesions | Procedure: Low fluorescence Photodynamic therapy<br>* 42 J/cm2 for 72 sec<br>Procedure: core pars plana vitrectomy<br>* 24 hours after photodynamic therapy, 1.5 mL core pars plana vitrectomy<br>Drug: dexamethasone<br>* intravitreal injection of 0.8 mg dexamethasone<br>Drug: bevacizumab<br>* intravitreal injection of 1.25 mg bevacizumab<br>|
| Experimental: 2<br>eyes with occult lesions | Drug: bevacizumab<br>* intravitreal injection of 1.25 mg bevacizumab<br>Procedure: core pars plana vitrectomy<br>* 0.4 mL core pars plana vitrectomy<br>Drug: triamcincolone<br>* intravitreal injection of 8 mg triamcincolone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity |  | at the day of exam | 
| Central macular thickness |  | at the day of exam | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ARMD, combined therapy, efficacy, safety