Functional versus functional and anatomical criteria-guided ranibizumab treatment in patients with neovascular age-related macular degeneration – results from the randomized, phase IIIb OCTAVE study

Abstract Background To evaluate the efficacy and safety of two individualized ranibizumab retreatment schemes in neovascular age-related macular degeneration. Methods Patients (N = 671) were randomized (1:1) to receive three initial monthly ranibizumab 0.5 mg injections, then retreatment guided by either best-corrected visual acuity (BCVA) loss (Group I) or BCVA loss and/or signs of disease activity on optical coherence tomography (OCT; Group II). The study was terminated prematurely and the decision to discontinue the study was made by the sponsor. Efficacy analyses were performed on patients who completed 12 months of the originally planned 24-month study. Safety analyses are presented for all safety analyzable patients. Results Of 671 randomized patients, 305 completed 12 months of the study. For the 12-month completers, baseline mean (standard deviation) BCVA and reading-center evaluated central subfield thickness (CSFT) were comparable [Group I: 60.9 (13.10) letters and 517.7(201.79) μm; Group II: 60.2 (12.21) letters and 515.3 (198.37) μm]. The change from baseline at Month 12 in BCVA was 6.7 (13.48) letters in Group I and 8.3 (13.53) letters in Group II and the change in CSFT was − 161.3 (163.48) μm and − 175.3 (170.45) μm, respectively. The mean number of ranibizumab injections was 8.2 in Group I and 8.4 in Group II. Conclusion Ranibizumab treatment resulted in visual and anatomic gains at 12 months for both retreatment strategies, with a trend in favor of OCT-guided vs BCVA loss guided retreatment. No new safety signals were seen. Trial registration www.ClinicalTrials.gov (NCT01780935). Registered 31 January 2013.

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Functional versus functional and anatomical criteria-guided ranibizumab treatment in patients with neovascular age-related macular degeneration – results from the randomized, phase IIIb OCTAVE study

10.21203/rs.2.9419/v3 ◽

2019 ◽

Author(s):

Giovanni Staurenghi ◽

Justus G. Garweg ◽

Bianca S. Gerendas ◽

Wayne Macfadden ◽

Boris Gekkiev ◽

...

Keyword(s):

Macular Degeneration ◽

Age Related Macular Degeneration ◽

Comparable Group ◽

Age Related ◽

Group I ◽

Central Subfield Thickness ◽

Phase Iiib ◽

Group Ii ◽

Reading Center ◽

Ranibizumab Treatment

Abstract Background: To evaluate the efficacy and safety of two individualized ranibizumab retreatment schemes in neovascular age-related macular degeneration. Methods: Patients (N=671) were randomized (1:1) to receive three initial monthly ranibizumab 0.5 mg injections, then retreatment guided by either best-corrected visual acuity (BCVA) loss (Group I) or BCVA loss and/or signs of disease activity on optical coherence tomography (OCT; Group II). The study was terminated prematurely and the decision to discontinue the study was made by the sponsor. Efficacy analyses were performed on patients who completed 12 months of the originally planned 24-month study. Safety analyses are presented for all safety analyzable patients. Results: Of 671 randomized patients, 305 completed 12 months of the study. For the 12-month completers, baseline mean (standard deviation) BCVA and reading-center evaluated central subfield thickness (CSFT) were comparable [Group I: 60.9 (13.10) letters and 517.7(201.79) µm; Group II: 60.2 (12.21) letters and 515.3 (198.37) µm]. The change from baseline at Month 12 in BCVA was 6.7 (13.48) letters in Group I and 8.3 (13.53) letters in Group II and the change in CSFT was −161.3 (163.48) µm and −175.3 (170.45) µm, respectively. The mean number of ranibizumab injections was 8.2 in Group I and 8.4 in Group II. Conclusion: Ranibizumab treatment resulted in visual and anatomic gains at 12 months for both retreatment strategies, with a trend in favor of OCT-guided vs BCVA loss guided retreatment. No new safety signals were seen.

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Functional versus functional and anatomical criteria-guided ranibizumab treatment in patients with neovascular age-related macular degeneration – results from the randomized, phase IIIb OCTAVE study

10.21203/rs.2.9419/v2 ◽

2019 ◽

Author(s):

Giovanni Staurenghi ◽

Justus G. Garweg ◽

Bianca S. Gerendas ◽

Wayne Macfadden ◽

Boris Gekkiev ◽

...

Keyword(s):

Disease Activity ◽

Age Related Macular Degeneration ◽

Comparable Group ◽

Age Related ◽

Group I ◽

Central Subfield Thickness ◽

Phase Iiib ◽

Group Ii ◽

Reading Center ◽

Ranibizumab Treatment

Abstract Background To evaluate the efficacy and safety of two individualized ranibizumab retreatment schemes in neovascular age-related macular degeneration.Methods Patients (N=671) were randomized (1:1) to receive three initial monthly ranibizumab 0.5 mg injections, then retreatment guided by either best-corrected visual acuity (BCVA) loss (Group I) or BCVA loss and/or signs of disease activity on optical coherence tomography (OCT; Group II). The study was terminated prematurely, as OCT-guided disease activity monitoring became a recommended retreatment criteria. Efficacy analyses were performed on patients who completed 12 months of the originally planned 24-month study. Safety analyses are presented for all safety analyzable patients.Results Of 671 randomized patients, 305 completed 12 months of the study. For the 12-month completers, baseline mean (standard deviation) BCVA and reading-center evaluated central subfield thickness (CSFT) were comparable [Group I: 60.9 (13.10) letters and 517.7(201.79) µm; Group II: 60.2 (12.21) letters and 515.3 (198.37) µm]. The change from baseline at Month 12 in BCVA was 6.7 (13.48) letters in Group I and 8.3 (13.53) letters in Group II and the change in CSFT was −161.3 (163.48) µm and −175.3 (170.45) µm, respectively. The mean number of ranibizumab injections was 8.2 in Group I and 8.4 in Group II.Conclusion Ranibizumab treatment resulted in visual and anatomic gains at 12 months for both retreatment strategies, with a trend in favor of OCT-guided vs BCVA loss guided retreatment. No new safety signals were seen.

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Functional versus functional and anatomical criteria-guided ranibizumab treatment in patients with neovascular age-related macular degeneration – results from the randomized, phase IIIb OCTAVE study

10.21203/rs.2.9419/v1 ◽

2019 ◽

Author(s):

Giovanni Staurenghi ◽

Justus G. Garweg ◽

Bianca S. Gerendas ◽

Wayne Macfadden ◽

Boris Gekkiev ◽

...

Keyword(s):

Macular Degeneration ◽

Standard Of Care ◽

Age Related Macular Degeneration ◽

Age Related ◽

Group I ◽

Phase Iiib ◽

The Mean ◽

Group Ii ◽

Post Hoc ◽

Ranibizumab Treatment

Abstract Background: To evaluate the efficacy and safety of two individualized ranibizumab retreatment schemes in neovascular age-related macular degeneration. Methods: Patients (N=671) were randomized (1:1) to receive three initial monthly ranibizumab 0.5 mg injections, then retreatment guided by either best-corrected visual acuity (BCVA) loss (Group I) or BCVA loss and/or signs of disease activity on optical coherence tomography (OCT; Group II). The study was terminated prematurely, as OCT-guided treatment became standard of care during the study period. Post-hoc efficacy analyses were performed on patients who completed 12 months of the originally planned 24-month study. Safety analyses are presented for all safety analyzable patients. Results: Of 671 randomized patients, 305 completed 12 months. At baseline, the mean (standard deviation) BCVA and reading-center evaluated central subfield thickness (CSFT) were 60.9 (13.10) letters and 517.7(201.79) µm, respectively in Group I and 60.2 (12.21) letters and 515.3 (198.37) µm in Group II. The change from baseline at Month 12 in BCVA was 6.7 (13.48) letters in Group I and 8.3 (13.53) letters in Group II and the change in CSFT was −161.3 (163.48) µm and −175.3 (170.45) µm, respectively. The mean number of injections was 8.2 in Group I and 8.4 in Group II. Conclusion: Ranibizumab treatment resulted in visual and anatomic gains at 12 months for both retreatment strategies, with a trend in favor of OCT-guided vs BCVA loss guided retreatment. No new safety signals were seen.

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Functional versus functional and anatomical criteria-guided ranibizumab treatment in patients with neovascular age-related macular degeneration – results from the randomized, phase IIIb OCTAVE study

10.21203/rs.2.9419/v4 ◽

2019 ◽

Author(s):

Giovanni Staurenghi ◽

Justus G. Garweg ◽

Bianca S. Gerendas ◽

Wayne Macfadden ◽

Boris Gekkiev ◽

...

Keyword(s):

Optical Coherence Tomography ◽

Visual Acuity ◽

Macular Degeneration ◽

Age Related Macular Degeneration ◽

Corrected Visual Acuity ◽

Age Related ◽

Group I ◽

Group Ii ◽

Best Corrected Visual Acuity ◽

Ranibizumab Treatment

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Mingjing granule, a traditional Chinese medicine in the treatment of neovascular age-related macular degeneration: study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-021-05025-x ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Yamin Li ◽

Lina Liang ◽

Torkel Snellingen ◽

Kai Xu ◽

Yun Gao ◽

...

Keyword(s):

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Macular Degeneration ◽

Vision Loss ◽

Age Related Macular Degeneration ◽

Case Report Form ◽

Link Type ◽

Anti Vegf ◽

Age Related ◽

Function Test

Abstract Background Neovascular age-related macular degeneration (nAMD) is the most common cause of irreversible vision loss and blindness among the older people aged 50 and over. Although anti-vascular endothelial growth factor (anti-VEGF) therapies have resulted in improving patient outcomes, there are limitations associated with these treatments. In China, traditional Chinese medicine (TCM) has been used to treat eye diseases for more than 2000 years. Previous studies have shown that TCM may be beneficial for nAMD patients. However, explicit evidence has not been obtained. The purpose of the present trial is to examine the efficacy and safety of the Mingjing granule, a compound Chinese herbal medicine, for nAMD patients. Methods/design This is a double-blind, placebo-controlled, randomized trial of Mingjing granule as an add-on to intravitreous ranibizumab for nAMD. One hundred eighty nAMD patients from six hospitals in China will be enrolled according to the inclusion and exclusion criteria and randomly allocated into two groups, 90 in each. All participants will receive a 24-week treatment and then be followed up for another 24 weeks. The primary outcome is the mean change of best-corrected visual acuity at week 24 and 48 as compared to the baseline. The secondary outcomes include mean change in central retinal thickness, area of retinal hemorrhage and exudation, and TCM syndrome score, mean number of intravitreal ranibizumab injection, and total cost of the treatment. Indexes of safety include blood regular test, urine regular test, liver function test, renal function test, and electrocardiogram from baseline to weeks 24 and 48. Qualitative control and some standard operating processes will be formed throughout the trial. Any ocular or systemic adverse events will be treated suitably, and related data will be recorded accurately and completely in the case report form. Discussion Based on previous empirical and animal laboratory studies, this study will address the question of whether Mingjing granule could contribute to improving efficacy, safety, and efficiency with need for fewer intravitreal injections of anti-VEGF, improving compliance and visual outcomes in the management of persons with nAMD. Trial registration Chinese Clinical Trial Registry (http://www.chictr.org.cn), ChiCTR2000035990. Registered on 21 August 2020.

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Ranibizumab treatment in patients with neovascular age-related macular degeneration and very low vision

Acta Ophthalmologica ◽

10.1111/j.1755-3768.2010.01899.x ◽

2010 ◽

Vol 89 (1) ◽

pp. e97-e97 ◽

Cited By ~ 5

Author(s):

Torben Lykke Sørensen ◽

Henrik Kemp

Keyword(s):

Macular Degeneration ◽

Low Vision ◽

Age Related Macular Degeneration ◽

Age Related ◽

Ranibizumab Treatment

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Estimated Cases of Blindness and Visual Impairment from Neovascular Age-Related Macular Degeneration Avoided in Australia by Ranibizumab Treatment

PLoS ONE ◽

10.1371/journal.pone.0101072 ◽

2014 ◽

Vol 9 (6) ◽

pp. e101072 ◽

Cited By ~ 32

Author(s):

Paul Mitchell ◽

Neil Bressler ◽

Quan V. Doan ◽

Chantal Dolan ◽

Alberto Ferreira ◽

...

Keyword(s):

Visual Impairment ◽

Macular Degeneration ◽

Age Related Macular Degeneration ◽

Age Related ◽

Ranibizumab Treatment

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Aflibercept for age-related macular degeneration: 4-year outcomes of a ‘treat-and-extend’ regimen with exit-strategy

British Journal of Ophthalmology ◽

10.1136/bjophthalmol-2020-316514 ◽

2020 ◽

pp. bjophthalmol-2020-316514

Author(s):

Damian Jaggi ◽

Thanoosha Nagamany ◽

Andreas Ebneter ◽

Marion Munk ◽

Sebastian Wolf ◽

...

Keyword(s):

Macular Degeneration ◽

Age Related Macular Degeneration ◽

Long Term Outcomes ◽

Treat And Extend ◽

Age Related ◽

Central Subfield Thickness ◽

Treatment Naïve ◽

Treat And Extend Regimen

AimTo report long-term outcomes on best-corrected visual acuity (BCVA) and treatment intervals with a treat-and-extend (T&E) regimen in patients with neovascular age-related macular degeneration (nAMD).MethodsThis observational study included treatment-naïve patients with nAMD, treated with aflibercept. A specific T&E protocol without a loading phase and predefined exit criteria was administered. After reaching predefined ‘exit-criteria’, the treatment period was complete, and patients were observed three monthly.ResultsEighty-two patients with a follow-up period of ≥2 years were included. BCVA (mean±SD, ETDRS letters) increased from 51.9±25.2 at baseline to 63.7±17.7 (p<0.0001) at 1 year, 61.7±18.5 (p<0.0001) at 2 years, 62.4±19.5 (p<0.0001, n=61) at 3 years and remained insignificantly higher than baseline at 4 years at 58.5±24.3 (p=0.22). Central subfield thickness (mean±SD, μm) decreased significantly from 387.5±107.6 (p<0.0001) at baseline to 291.9±65.5 (p<0.0001) at 1 year, and remained significantly lower until 4 years at 289.0±59.4 (p<0.0001). Treatment intervals (mean±SD, weeks) could be extended up to 9.3±3.1 weeks at 1 year and remained at 11.2±3.5 weeks at 4 years. Twenty-nine (35%) patients reached exit criteria and continued with three monthly observation only.ConclusionsAfter 4 years of treatment, initial vision gains were maintained with a reasonable treatment burden, even without an initial loading phase. Our results on functional outcomes are comparable with large controlled studies.

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