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  5. FP1643 : “OCTA guided PDT” in Polypoidal Choroidal Vasculopathy: A novel approach

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Dr. Vineet Mutha, M18128, Dr. Prateek
Kakkar, Dr. Dheepak Sundar Malaravannan,Dr. Atul Kumar

Introduction 

Polypoidal Choroidal Vasculopathy (PCV) was first described by Yannuzzi, et al in 1990 as an entity leading to exudation and hemorrhage under macula.1 At present, PCV is considered as a subtype of neovascular age related macular degeneration.2 Disease spectrum includes clinical appearance of multiple, nodular, orange, recurrent serosanguinous macular detachments (60%) leading to metamorphopsia, decreased visual acuity and contrast sensitivity.3 Multiple imaging modalities can be utilized for diagnosis but the gold standard remains Indocyanine Green Angiography (ICGA) with characteristic features of hyperfluorescent polyps (90%) with hypofluorescent halos (60%) and branching vascular network (BVN) (80%).4 Spectral Domain Optical Coherence Tomography (SDOCT) reveals multiple pigment epithelial detachments (PEDs), Thumb Like Polyps (TLP) with corresponding leakage on ICGA, Double Layer Sign (DLS) and a distinct tomographic notch.5 Recently with availability of OCT Angiography (OCTA), many centres around the globe are comparing its “efficacy of diagnosing PCV” with ICGA and present evidence is suggestive of almost similar diagnosing capabilities.6

Epidemiological data suggest a preponderance of PCV in Asians with a much higher prevalence than caucasians.7Among the risk factors described in literature; most important are hypertension, diabetes, smoking and end stage renal disease (ESRD).8 Role of various genes such as Age Related Maculopathy Susceptibility-2 (ARMS2) and Complement Factor H (CFH) has also been described.9 PCV is more common in males (70-80%) and usually occurs after 60 years of age though it may occur in less than 50 years of age as in patients with Central Serous Choroidopathy (CSC).8 Similar epidemiological profile is seen in Indian population also.10 Some of the factors such as stress, sleep, exercise, diet, obesity and sun exposure have never been evaluated for association with PCV.

Among the various treatment modalities, landmark study “EVEREST” has shown resolution of PCV lesions with verteporfin based standard fluence Photo Dynamic Therapy (sfPDT) alone or combined with ranibizumab to be better than the latter alone.11 Aflibercept 2mg/0.05 ml has been shown to reduce PCV lesions by around 70% at 6 months with monthly treatment for initial 3 months in “EPIC” study.12 Reduced fluenceverteporfin PDT (rfPDT) at 25 J/cm2 along with ranibizumab is equivalent to sfPDT done at 50 J/cm2 alone with less adverse effects such as decreased visual acuity and post treatment lipid exudation in patients with PCV.13 For PDT, Greatest Linear Dimension (GLD) measures the area to be treated on ICGA and laser spot is given accordingly.

Most common ocular complication noticed with PDT or antiVEGF drugs in PCV according to landmark EVEREST trial is retinal hemorrhage (5/61 patients) and nonocular complications are angina and hypertension which were very rare (1/61 patients).13

Review of literature

  1. Anantharaman G, Ramkumar G, Gopalakrishnan M, Rajput A – Clinical features, management and visual outcome of polypoidal choroidal vasculopathy in Indian patients. Indian J Ophthalmol 2010; 58; 5; 399:- PCV is an important differential diagnosis in patients presenting with serosanginous maculopathy and submacular hemorrhage. The disease was more prevalent in males and was unilateral in the Indian population. Timely intervention in cases with symptomatic polyps could achieve stabilization of visual acuity. Thermal laser and PDT were safe and effective.
  2. Sakurada Y, Yoneyama S, Imasawa M, Iijima H. Systemic risk factors associated with polypoidal choroidal vasculopathy and neovascular age-related macular degeneration. Retina (Philadelphia, Pa). 2013 Apr;33(4):841–5:-Diabetes mellitus and end-stage renal disease are more prevalent in patients with nAMD than in those with PCV. Specific systemic conditions might be associated with the development of nAMD.
  3. Mayer Srour,Giuseppe Querques,Oudy Semoun, Ala El Ameen, Alexandra Miere, Anne Sikorav, Olivia Zambrowski, Eric H Souied:Optical coherence tomography angiography characteristics of polypoidal choroidal vasculopathy. British Journal of Ophthalmology. https://bjo.bmj.com/content/early/2016/02/02/bjophthalmol-2015-307892.short?rss=1: Optical coherence tomography angiography is a noninvasive imaging tool for detecting vascular changes in PCV. Branching vascular networks showed more clearly on OCTA than on ICGA. Polypoidal lesions had variable patterns on OCTA and were not always detected. The OCTA patterns of the polypoidal lesions and the BVN are helpful in understanding the pathology of PCV.
  4. Koh A, Lee WK, Chen L-J, Chen S-J, Hashad Y, Kim H, et al. EVEREST study: efficacy and safety of verteporfin photodynamic therapy in combination with ranibizumab or alone versus ranibizumab monotherapy in patients with symptomatic macular polypoidal choroidal vasculopathy. Retina (Philadelphia, Pa). 2012 Sep;32(8):1453–64.: Verteporfin PDT combined with ranibizumab 0.5 mg or alone was superior to ranibizumab monotherapy in achieving complete regression of polyps in this 6-month study in patients with symptomatic macular polypoidal choroidal vasculopathy. All treatments were well tolerated over 6 months. This study also demonstrated the role of ICGA in diagnosing PCV.
  5. Sagong M, Lim S, Chang W. Reduced-fluence photodynamic therapy combined with intravitrealbevacizumab for polypoidal choroidal vasculopathy. Am J Ophthalmol. 2012 May;153(5):873–882.e2:-Reduced-fluence PDT combined with bevacizumab for PCV seemed to be effective for improving vision and reducing complications.
  6. Yamashita A, Shiraga F, Shiragami C, Shirakata Y, Fujiwara A. Two-year results of reduced-fluence photodynamic therapy for polypoidal choroidal vasculopathy. Am J Ophthalmol. 2013 Jan;155(1):96–102.e1:-Reduced-fluence PDT monotherapy for PCV effectively improved and maintained the VA over a 24-month period, even in eyes with a baseline VA better than 20/40. In addition, the number of treatments could be much smaller as compared with intravitreal injection of anti-vascular endothelial growth factor agents

cunae in literature

  • There is no study suggesting the role of OCTA guided GLD in treatment of PCV with PDT. Thus a comparison of OCTA guided GLD measurement with ICGA guided GLD measurement has never been pursued. 

Aims and objectives

  • To compare the role of OCTA guided PDT versus ICGA guided PDT in treatment of PCV.

Materials and methods

 Study Design:

This is a randomised prospective comparative interventional study. This study was conducted after ethical clearance from the institute ethics committee. All patients were recruited only after their full free voluntary written informed consent.

Methodology:

A total of 40 patients were recruited in this study with symptomatic ICGA diagnosed PCV in one or both the eyes with or without previous PDT or Anti Vascular Endothelial Growth Factor (anti-VEGF) therapy. After a detailed history, ETDRS visual acuity, near vision testing on Snellen near vision chart and non contact tonometry (NCT), clinically suspected patients on 90 D biomicroscopy underwent an ICGA + FFA + SDOCT evaluation on Spectralis (Heidelberg engineering, Heidelberg, Germany). Definitive diagnosis was based on ICGA pictures showing any one of the following within first 6 minutes of injection: 1) nodular hyperfluorescence suggestive of polyps, 2) branching vascular network or 3) Hypofluorescent halo and GLD on ICGA was measured simultaneously and only those patients who had a GLD less than 6000 microns were recruited.

At baseline, the recruited patients underwent contrast sensitivity evaluation with Pelli Robson contrast sensitivity chart, fundus Clinical Picture (CP) with measurement of size of lesion apparent clinically, swept source OCT (SSOCT) examination with measurement of Central Choroidal Thickness (CCT), Central Macular Thickness (CMT) and Maximum Height of PED (PEDmax) and OCTA was done subsequently with documentation of BVN, polyps and the GLD. Both SSOCT and OCTA were done on Triton (Topcon, Japan).

The patients were then randomized for treatment regimen. Patients were classified into two groups – O) OCTA based GLD guided PDT and I) ICGA based GLD guided PDT.

Follow up:

Post PDT patients were followed up monthly for 6 months. ETDRS visual acuity, Snellen near vision acuity, NCT, Pelli Robson contrast sensitivity, fundus CP, OCTA with measurement of GLD and analysis of BVN and polyps; SSOCT with measurement of CMT, CCT and PEDmax; and SDOCT was performed monthly for 6 months while ICGA and FFA were done at 0, 3 and 6 months. Any treatment related ocular and non ocular complications were documented and managed accordingly.

Statistical analysis:

Data was entered into microsoft excel spreadsheet and analysed with SPSS software. For categorical variables, Chi-square test was applied for descriptive analysis. To compare continuous variables, independent sample t test was be applied. A ‘p value’ of less than 0.05 was be considered significant.

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