A Study on the Effectiveness of Combining Ranibizumab and Dexamethasone Implants for Treating Macular Edema in Retinal Vein Occlusion and Diabetic Eye Disease

doi:10.21203/rs.3.rs-4937457/v1

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Research Article

A Study on the Effectiveness of Combining Ranibizumab and Dexamethasone Implants for Treating Macular Edema in Retinal Vein Occlusion and Diabetic Eye Disease

https://doi.org/10.21203/rs.3.rs-4937457/v1

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Background

Macular edema (ME), a leading cause of vision impairment, is common in patients with retinal vein occlusion (RVO) and diabetic macular edema (DME). This study evaluates the efficacy and safety of combining ranibizumab, an anti-vascular endothelial growth factor (anti-VEGF) agent, with dexamethasone implants for treating ME secondary to RVO and DME.

Methods

This retrospective study involved 61 patients diagnosed with ME secondary to RVO (n = 48) or DME (n = 13) treated at Ningbo Ophthalmology Hospital, China. All patients received intravitreal injections of ranibizumab and dexamethasone implants, with outcomes measured at baseline, 1, 3, and 6 months post-treatment. Primary outcomes included best-corrected visual acuity (BCVA), central retinal thickness (CRT), vascular endothelial growth factor (VEGF) and intercellular adhesion molecule-1 (ICAM-1) levels, and intraocular pressure (IOP).

Results

Both RVO and DME groups showed significant improvement in BCVA, with the DME group demonstrating more sustained benefits. CRT decreased significantly at 1 month post-treatment and remained lower than baseline at 3 and 6 months. Although VEGF and ICAM-1 levels showed reductions post-treatment, these changes were not statistically significant. IOP increased at 1 month but returned to baseline by 3 months and remained stable.

Conclusions

Combining ranibizumab with dexamethasone implants effectively reduces ME and improves visual outcomes in RVO and DME patients, with a manageable safety profile. Further studies are needed to validate these findings and refine long-term treatment protocols.

Diabetic Macular Edema

Retinal Vein Occlusion

Anti-VEGF Therapy

Dexamethasone

Macular edema (ME) is a leading cause of visual impairment and blindness. It commonly affects patients with retinal vein occlusion (RVO) and diabetic retinopathy, two of the most prevalent retinal vascular disorders. ME results from fluid accumulation in the macula, which occurs due to the breakdown of the blood-retinal barrier. This breakdown leads to retinal thickening and eventually causes vision loss(1, 2). Over the past decade, the treatment of ME has seen revolutionary advancements through intravitreal therapies. Anti-vascular endothelial growth factor (anti-VEGF) agents and corticosteroids, in particular, have led to significant improvements in visual outcomes and reductions in macular thickness(3, 4).

Anti-VEGF agents, such as ranibizumab and aflibercept, are widely used as first-line treatments for ME secondary to RVO and diabetic macular edema (DME). These agents effectively decrease vascular permeability and abnormal neovascularization(5, 6). However, a significant proportion of patients show suboptimal responses to these treatments. This highlights the need for alternative or adjunctive therapies to enhance ME management(7).

Corticosteroids, like dexamethasone, particularly in sustained-release implant form (e.g., Ozurdex), offer an effective alternative. They help by reducing inflammation and stabilizing the blood-retinal barrier. These implants provide prolonged drug release, reducing the frequency of injections and ensuring sustained therapeutic effects, especially in patients who do not respond to anti-VEGF therapy(6, 8). Ding et al. suggested that anti-inflammatory therapy might be more effective than anti-VEGF therapy in reducing serous retinal detachment and hyperreflective dots(9).

Recent studies have explored the combination of anti-VEGF agents and corticosteroids, leveraging their complementary mechanisms. This combination therapy has shown promise in improving outcomes for patients with persistent ME, offering greater efficacy in reducing macular thickness and enhancing visual acuity(5, 10). However, the comparative efficacy and safety of combination therapy versus monotherapy are still under investigation. Some studies have reported a higher risk of adverse events, such as elevated intraocular pressure(11).

To optimize ME treatment strategies, our study evaluates the clinical outcomes of combining ranibizumab and dexamethasone implants in patients with ME secondary to RVO and DME. The study examines changes in visual acuity, central retinal thickness, and biomarker levels, aiming to provide deeper insights into the efficacy and safety of this combination therapy.

Study Design and Participants

This retrospective observational study was conducted at Ningbo Ophthalmology Hospital in Zhejiang Province, China, between October 2020 and November 2021. A total of 61 patients diagnosed with ME secondary to retinal vein occlusion (RVO-ME) or diabetic macular edema (DME) were enrolled in the study. The cohort consisted of 48 patients in the RVO-ME group and 13 patients in the DME group. Comprehensive ophthalmic examinations, including Optical Coherence Tomography (OCT), Fundus Fluorescein Angiography (FFA), slit-lamp examination with a fundus lens, and fundus photography, were performed to confirm the diagnosis.

All methods were performed in accordance with the relevant guidelines and regulations. Written informed consent was obtained from all participants, and the study protocol adhered to the principles of the Declaration of Helsinki and was approved by the Ethics Committee of Ningbo Ophthalmology Hospital.

Inclusion and Exclusion Criteria

Inclusion criteria included: (1) adult patients aged 18 years or older who provided written informed consent, (2) confirmed diagnosis of ME secondary to RVO or DME with central retinal thickness (CRT) ≥ 250 µm as measured by OCT, and (3) availability for follow-up for at least 3 months.

Exclusion criteria included: (1) prior intravitreal injection of anti-VEGF or corticosteroid drugs within 3 months prior to treatment, (2) prior retinal laser therapy within 1 month before treatment, (3) history of ocular surgery within 3 months before treatment, (4) presence of other macular diseases or conditions that could affect treatment outcomes, such as retinal pigment epithelial atrophy or macular hole, (5) systemic diseases that could affect the study, such as recent myocardial infarction, (6) media opacities that precluded clear OCT imaging, (7) optic nerve diseases or congenital abnormalities that could interfere with visual outcome assessments, and (8) inability to comply with follow-up visits.

Treatment Protocol

All patients received a combination therapy consisting of intravitreal injections of ranibizumab and dexamethasone implant (Ozurdex). The treatments were administered in accordance with established clinical guidelines, with follow-up assessments conducted at baseline, 1 month, 3 months, and 6 months post-treatment. Aqueous humor samples were collected before treatment and at 1 and 3 months post-treatment to measure the concentrations of vascular endothelial growth factor (VEGF) and intercellular adhesion molecule-1 (ICAM-1).

Outcome Measures

Primary outcome measures included changes in Best Corrected Visual Acuity (BCVA), CRT, VEGF, ICAM-1 levels, and intraocular pressure (IOP). BCVA was measured using a standardized 5-meter "E" visual acuity chart. CRT was measured using the Spectralis spectral-domain OCT system (Heidelberg Engineering, Germany), categorizing the measurements into horizontal CRT (H-CRT) and vertical CRT (V-CRT). IOP was measured using a non-contact tonometer (Topcon, Japan), with additional measurements using an ICARE rebound tonometer (ICARE, Finland) when necessary. VEGF levels were quantified using the Human VEGF ValukineTM ELISA kit (Bio-Techne, China), and ICAM-1 concentrations were measured using the Human sICAM-1/CD54 ELISA kit (MULTI SCIENCES, China).

Statistical Analysis

Data were analyzed using SPSS version 20.0, and graphical representations were generated using GraphPad Prism version 8.0. Continuous variables are presented as means ± standard deviations. Repeated measures analysis of variance (ANOVA) was used to analyze changes over time within groups, with post hoc comparisons performed using the least significant difference (LSD) test. Independent t-tests were used for between-group comparisons at corresponding time points, and chi-square tests were employed to assess differences in categorical variables. Statistical significance was defined as P < 0.05.

Demographic and Clinical Characteristics

As shown in Table 1, among the 61 subjects included, 48 were in the RVO-ME group and 13 in the DME group. There were no significant differences between the groups in terms of gender distribution, age, eye category, or hypertension prevalence (P > 0.05). Baseline BCVA, H-CRT, VEGF levels, ICAM-1 levels, and IOP were also comparable between the groups (P > 0.05). However, a significant difference was observed in V-CRT between the groups (P = 0.015), with V-CRT being significantly higher in the RVO-ME group compared to the DME group. This suggests that the degree of retinal edema may have been more severe in the RVO-ME group prior to treatment.

Table 1

Characteristics of all included subjects
Variables	Total(n = 61)	RVO-ME(n = 48)	DME(n = 13)	t/χ²	P
Gender				0.62	0.433
Male	34(55.74)	28(58.33)	6(46.15)
Female	27(44.26)	20(41.67)	7(53.85)
Age	61.21 ± 9.42	61.73 ± 9.57	59.31 ± 8.93	0.82	0.416
Eye category				0.85	0.356
Right	35(57.38)	29(60.42)	6(46.15)
Left	26(42.62)	19(39.58)	7(53.85)
Hypertension				0.42	0.517
No	28(45.90)	21(43.75)	7(53.85)
Yes	33(54.10)	27(56.25)	6(46.15)
BCVA	0.19 ± 0.17	0.20 ± 0.18	0.17 ± 0.14	0.47	0.642
H-CRT	662.00 ± 232.10	697.38 ± 226.94	520.50 ± 213.32	1.73	0.095
V-CRT	654.29 ± 234.63	712.00 ± 222.47	435.00 ± 133.82	2.64	0.015
VEGF	311.71 ± 291.06	382.57 ± 324.49	152.26 ± 95.51	1.36	0.200
ICAM-1	1189.08 ± 999.93	1401.50 ± 1134.94	711.14 ± 352.97	1.17	0.268
IOP	15.97 ± 2.17	16.04 ± 2.25	15.67 ± 1.97	0.37	0.712

Best Corrected Visual Acuity (BCVA) Changes

As shown in Table 2 and Fig. 1, In the RVO-ME group, BCVA significantly improved at 1 month post-treatment (P < 0.05), but returned to baseline levels by 3 months and showed no further significant improvement at 6 months. In contrast, the DME group showed significant BCVA improvement at both 1 month and 3 months post-treatment (P < 0.05), with continued improvement at 3 months, indicating a more sustained therapeutic effect in the DME group. Overall, both groups exhibited initial improvement in BCVA over time, but the DME group demonstrated a more prolonged and effective response. Figure 2 shows fundus images of three typical patients with branch retinal vein occlusion (BRVO), central retinal vein occlusion (CRVO), and DME, illustrating favorable treatment outcomes at 1 month, 3 months, and 6 months after combination therapy.

Table 2

Temporal Changes in Best Corrected Visual Acuity (BCVA)
BCVA	Baseline	1 month	3 months	6 months	P
RVO-ME	0.20 ± 0.18	0.27 ± 0.22a	0.20 ± 0.18b	0.19 ± 0.16b	0.001
DME	0.17 ± 0.14	0.24 ± 0.16a	0.28 ± 0.18a	0.21 ± 0.19	0.068
Total	0.19 ± 0.17	0.26 ± 0.21a	0.22 ± 0.18a	0.19 ± 0.16	0.012
P	0.642	0.747	0.380	0.714

a: compared with Baseline, P < 0.05; b: compared with 1 month, P < 0.05.

Central Retinal Thickness (CRT) Changes

As shown in Table 3, at 1 month post-treatment, both H-CRT and V-CRT significantly decreased in all patients (P < 0.05), indicating a substantial reduction in retinal edema. Although there was a trend of gradual increase in H-CRT and V-CRT at 3 and 6 months, the values remained significantly different from baseline (P < 0.05). This suggests that the long-term efficacy of the treatment is still favorable, as retinal edema did not fully return to the initial levels, indicating a sustained therapeutic effect. Figure 3 presents the horizontal central retinal thickness (H-CRT) in typical cases from the BRVO, CRVO, and DME groups, demonstrating favorable treatment outcomes.

Table 3

Temporal Changes in Central Retinal Thickness (CRT)
CRT	Baseline	1 month	3 months	6 months	P
H-CRT	662.00 ± 232.10	261.63 ± 134.04a	455.5 ± 307.72ab	537.30 ± 255.55ab	< 0.001
V-CRT	654.29 ± 234.63	281.17 ± 168.30a	452.88 ± 286.35ab	542.38 ± 215.01ab	< 0.001

a: compared with Baseline, P < 0.05; b: compared with 1 month, P < 0.05.

VEGF and ICAM-1 Levels

As shown in Table 4, in all patients, VEGF levels decreased significantly at 1 month post-treatment, although the P-value was > 0.05, which may be attributed to the small sample size. VEGF levels showed a slight rebound over the following 3 months, with no statistically significant difference (P > 0.05). ICAM-1 levels significantly decreased at 1 month (P < 0.05), but increased slightly by 3 months, with the difference remaining significant (P < 0.05). These results suggest that anti-VEGF and corticosteroid therapy is overall effective in reducing inflammatory factors, though the effect diminishes somewhat after 3 months.

Table 4

Temporal Changes in VEGF and ICAM-1
Variables	Baseline	1 month	3 months	P
VEGF	311.71 ± 291.06	201.15 ± 215.79	278.47 ± 236.34	0.426
ICAM	1189.08 ± 999.93	811.96 ± 680.24a	1018.87 ± 899.72b	0.007

a: compared with Baseline, P < 0.05; b: compared with 1 month, P < 0.05.

Intraocular Pressure (IOP) Changes

As shown in Table 5, in the RVO-ME group, intraocular pressure (IOP) increased at 1 month post-treatment but significantly decreased at 3 months, with a statistically significant difference compared to the IOP at 1 month (P < 0.05). By 6 months, IOP gradually returned to below baseline levels. In the DME group, IOP changes were not significant at any time point (P > 0.05), indicating that the treatment had minimal impact on IOP.

Table 5

Temporal Changes in Intraocular Pressure (IOP)
IOP	Baseline	1 month	3 months	6 months	P
RVO-ME	16.04 ± 2.25	17.16 ± 3.05	15.68 ± 2.14b	15.28 ± 1.95b	0.014
DME	15.67 ± 1.97	16.33 ± 2.66	16.00 ± 3.10	17.33 ± 3.56	0.526
Total	15.97 ± 2.17	17.00 ± 2.96	15.74 ± 2.29	15.68 ± 2.41	0.472
P	0.712	0.547	0.765	0.060

a: compared with Baseline, P < 0.05; b: compared with 1 month, P < 0.05.

Recurrence Rates

As shown in Table 6, the recurrence rates between the two groups showed no significant difference during the follow-up period (P > 0.05), indicating that the combination of anti-VEGF and corticosteroid therapy provides a similar level of recurrence control in both RVO-ME and DME patients.

Table 6

The results of recurrence in both groups
Variables	Total(n = 61)	RVO-ME(n = 48)	DME(n = 13)	χ²	P
Recurrence,n(%)				0.62	0.433
No	27(44.26)	20(41.67)	7(53.85)
Yes	34(55.74)	28(58.33)	6(46.15)

This study evaluates the efficacy and safety of combining ranibizumab with dexamethasone implants (Ozurdex) for the treatment of macular edema (ME) secondary to retinal vein occlusion (RVO) and diabetic macular edema (DME). The results underscore the therapeutic advantages of this combination, particularly in reducing central retinal thickness (CRT) and improving best-corrected visual acuity (BCVA). These positive effects were sustained for up to six months following treatment.

Both the RVO-ME and DME groups showed significant improvements in BCVA. Notably, the DME group exhibited a more sustained improvement over time. This prolonged benefit may be attributable to the chronic inflammatory nature of DME, which appears to respond more effectively to the anti-inflammatory properties of dexamethasone combined with the anti-angiogenic effects of ranibizumab(12, 13). Previous studies have suggested that combination therapy offers particular advantages for patients with suboptimal responses to anti-VEGF monotherapy, further corroborating the findings of this study(14, 15). The synergistic interaction between dexamethasone and ranibizumab, which targets both inflammation and pathological neovascularization, likely contributes to the observed clinical benefits.

The most pronounced reduction in CRT was observed one month after treatment. Although a gradual increase in CRT was noted at the three- and six-month follow-ups, these values remained significantly lower than baseline levels, suggesting that combination therapy provides sustained reduction in retinal edema. The persistence of this effect is particularly important, as continued reductions in CRT are closely linked to improved visual outcomes and a decreased risk of ME recurrence(16). This finding highlights the long-term efficacy of the combination therapy in managing retinal edema and improving patient prognosis.

The study observed a reduction in VEGF and ICAM-1 levels following treatment, although these changes did not reach statistical significance, likely due to the limited sample size. Despite this, the observed trends suggest that the combination therapy exerts a positive influence on these biomarkers, both of which are crucial in the pathogenesis of ME(17). VEGF is a primary mediator of vascular permeability, and its inhibition is pivotal in reducing ME, while ICAM-1 plays a significant role in leukocyte adhesion and vascular inflammation, processes that are mitigated by dexamethasone(18, 19). The lack of statistical significance in the VEGF and ICAM-1 results underscores the necessity for larger-scale studies to validate these findings. Nevertheless, the trends align with the established mechanisms of action for both ranibizumab and dexamethasone, indicating that the combination therapy effectively targets multiple pathogenic pathways involved in ME(20).

One of the primary safety concerns with the use of corticosteroids, such as dexamethasone, is the potential for increased intraocular pressure (IOP). In our study, although IOP increased at one month post-treatment, it returned to baseline levels by three months and remained stable thereafter, suggesting that the combination therapy possesses a manageable safety profile(21). Even at its peak, IOP stayed within a clinically safe range, reinforcing the conclusion that the therapy is well-tolerated with appropriate monitoring(22). Notably, the DME group exhibited no significant changes in IOP throughout the study, further underscoring the safety of this combination therapy in this patient population. These findings are consistent with other studies, which have reported low incidences of significant IOP elevation with dexamethasone implants, particularly when used in conjunction with anti-VEGF agents(23).

The recurrence rates of ME were similar between the RVO-ME and DME groups, indicating that the combination therapy effectively controls the disease across both conditions. The gradual increase in central retinal thickness (CRT) observed after the initial reduction suggests that while the therapy is effective, ongoing treatment or monitoring may be required to sustain its benefits over the long term(18). This highlights the chronic nature of ME in both RVO and DME and the importance of developing treatment strategies that balance efficacy and safety over extended periods(24).

While this study provides valuable insights, it is important to acknowledge several limitations. These include a relatively small sample size and the absence of a control group receiving monotherapy. These limitations may have affected the statistical power of the biomarker analysis, potentially leading to less robust conclusions. They also limit the generalizability of the findings to a broader patient population(14, 25). Future randomized controlled trials with larger sample sizes are needed to confirm the efficacy and safety of combination therapy and to explore the potential benefits of alternative or adjunctive treatments.

In conclusion, the combination of ranibizumab and dexamethasone implants represents a promising treatment strategy for patients with ME secondary to RVO and DME. This therapy demonstrates significant efficacy in reducing macular edema and improving visual outcomes while maintaining a manageable safety profile. Although changes in VEGF and ICAM-1 levels were not statistically significant, the observed trends suggest a positive impact on inflammatory and angiogenic pathways. These findings contribute to the growing body of evidence supporting the use of combination therapy in ME management and underscore the need for further research to optimize long-term treatment outcomes.

Author Contributions

Conceptualization, Q.Y.; Methodology, L.C.; Formal analysis, J.Y.; Data curation, X.F. and H.L.; Writing—original draft preparation, X.F.; Writing—review and editing, Y.Z.; Supervision, Q.Y.; Funding acquisition, Q.Y.; All authors have read and agreed to publish the manuscript.

Data availability statement

Data supporting this study is available from the corresponding author upon reasonable request.

Conflicts of Interest

The authors report no conflicts of interest.

Ethics declarations

The study was approved by the Research Ethics Committee of Ningbo Eye Hospital, and informed consent was obtained from all participants.

Funding

This work was funded by the 2024 Yuyao Health and Wellness Science and Technology Program (2024YPT01) and the 2023 Yuyao Maternity and Child Health Care Hospital Science and Technology Program (2023YFB03).

Ethics Approval and Consent to Participate

This study was conducted in accordance with the Declaration of Helsinki and was approved by the Research Ethics Committee of Ningbo Eye Hospital (2023YFB03). Written informed consent was obtained from all participants prior to their inclusion in the study.

Consent for Publication

Not applicable.

Availability of Data and Materials

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Competing Interests

The authors declare that they have no competing interests.

Acknowledgements

We would like to thank all participants involved in this study and the staff at Ningbo Eye Hospital for their support during the study.

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You are reading this latest preprint version

A Study on the Effectiveness of Combining Ranibizumab and Dexamethasone Implants for Treating Macular Edema in Retinal Vein Occlusion and Diabetic Eye Disease

Status:

Version 1

Abstract

Background

Methods

Results

Conclusions

Figures

Introduction

Methods

Study Design and Participants

Inclusion and Exclusion Criteria

Treatment Protocol

Outcome Measures

Statistical Analysis

Results

Demographic and Clinical Characteristics

Best Corrected Visual Acuity (BCVA) Changes

Central Retinal Thickness (CRT) Changes

VEGF and ICAM-1 Levels

Intraocular Pressure (IOP) Changes

Recurrence Rates

Discussion

Declarations

References

Status:

Version 1